Delving into the Latest Updates on Tisagenlecleucel with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

Adoptive immunotherapy agent CTL019, Anti-CD19-CAR transduced T cells, Anti-CD19-chim

+ [10]

Target

CD19

Action

modulators

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators), T lymphocyte replacements

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

Recurrent B Acute Lymphoblastic LeukemiaRefractory B Acute Lymphoblastic LeukemiaCD19-positive B-cell acute lymphoblastic leukemia+ [14]

Inactive Indication

B-cell lymphoma refractoryCD19 positive Acute Lymphoblastic LeukemiaCD19 Positive B-Cell Chronic Lymphocytic Leukemia+ [10]

Originator Organization

Novartis Pharma AG

Active Organization

Novartis AG

University of PennsylvaniaNovartis Europharm Ltd.

+ [5]

Inactive Organization

Shanghai Cellular Biopharmaceutical Group Ltd.Abramson Cancer Center

License Organization

Shanghai AbelZeta Ltd.

Novartis AG

Drug Highest PhaseApproved

First Approval Date

United States (30 Aug 2017),

Diffuse Large B-Cell LymphomaHigh grade B-cell lymphomaPrecursor B-Cell Lymphoblastic Leukemia-Lymphoma

RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (South Korea), Regenerative Medicine Advanced Therapy (United States)

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Structure/Sequence

Sequence Code 631391916

The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.

Start Date13 May 2024

Sponsor / Collaborator

Stanford University

100 Clinical Results associated with Tisagenlecleucel

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100 Translational Medicine associated with Tisagenlecleucel

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100 Patents (Medical) associated with Tisagenlecleucel

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665

Literatures (Medical) associated with Tisagenlecleucel

01 Dec 2026·CURRENT TREATMENT OPTIONS IN ONCOLOGY

The Use of Targeted Therapy in Pediatric Acute Lymphoblastic Leukemia: Exploring Novel Approaches and Emerging Therapies

Review

Author: Krieger, Marissa ; Byrwa, David J ; Kelly, Kara M ; Niswander, Lisa M

Opinion Statement:

With modern risk stratification of multi-agent cytotoxic chemotherapy protocols, we now cure the majority of patients with pediatric acute lymphoblastic leukemia (ALL). However, patients with high-risk features or relapsed disease continue to have suboptimal outcomes. Conventional chemotherapy agents may increase long term organ toxicities even in more favorable patients. Improved understanding of the molecular characteristics of pediatric ALL has led to the preclinical and clinical development of more targeted and less systemically toxic therapeutic options for patients with ALL. Agents such as blinatumomab, inotuzumab ozogamicin, tisagenlecleucel and several others have revolutionized the treatment of relapsed or refractory ALL by either directing therapies locally to leukemic cells or by targeting specific leukemogenic pathways. Here we present current evidence for efficacy and toxicity profiles for these targeted therapies in pediatric patients with ALL. Many of these strategies have been more comprehensively studied in the adult population and we will highlight ongoing and needed clinical trials in pediatrics. We need to overcome our historically delayed approach to introducing new therapeutic options in pediatrics, as adults often benefit from innovations for years before they are evaluated in children. More proactively incorporating these emerging treatments into frontline therapy for the most vulnerable, high-risk pediatric ALL populations could meaningfully reshape our treatment paradigm. Earlier collaboration for development of clinical trials across pediatric and adult ALL may facilitate more rapid access to promising agents. We anticipate that successful upfront integration of more targeted approaches will improve response rates, reduce reliance on highly toxic chemotherapies and ultimately increase the likelihood of duration of remission. We expect the next generation of clinical trials will credential more targeted therapies for use in frontline therapy with the goal of improved outcomes with minimized toxicity for all patients with pediatric ALL, not just those with more favorable disease characteristics.

01 May 2026·CYTOTHERAPY

Low reticulocyte count at infusion is a risk factor for ICANS in CAR-T cell therapy

Article

Author: Jo, Tomoyasu ; Nishikori, Momoko ; Sakamoto, Takashi ; Nagao, Miki ; Kitawaki, Toshio ; Arai, Yasuyuki ; Takaori-Kondo, Akifumi ; Yoshinaga, Noriyoshi ; Shirakawa, Kotaro ; Yamashita, Kouhei ; Kanda, Junya ; Tashiro, Yusuke

INTRODUCTION:

Chimeric antigen receptor (CAR)-T cell therapies targeting CD19 have shown efficacy against B-cell malignancies. However, they frequently cause immune effector cell-associated neurotoxicity syndrome (ICANS), which can be life-threatening and require intensive care. Even when it is not severe, ICANS can lead to prolonged hospitalization and limit treatment options, especially for elderly patients. Despite its clinical significance, a reliable, early predictive marker for ICANS has not been identified.

METHODS:

To identify risk factors for ICANS, we retrospectively analyzed B-cell lymphoma patients who received tisagenlecleucel (tisa-cel), lisocabtagene maraleucel (liso-cel), or axicabtagene ciloleucel (axi-cel) at Kyoto University Hospital from 2019 to 2024.

RESULTS:

Among 106 patients, 76 received tisa-cel, 22 liso-cel, and eight axi-cel. Median age at infusion was 63.5 years (interquartile range, 57-69). Eight patients (8%) had a history of central nervous system (CNS) involvement. ICANS occurred in 17 patients (16%), all with prior cytokine-release syndrome (CRS). Reticulocyte counts at infusion were significantly lower in patients who subsequently developed ICANS (1.57 versus 2.80 × 104/μL, P < 0.01). Multivariate analysis identified a low reticulocyte count at infusion (HR, 3.67; 95% CI, 1.23-11.02; P = 0.02), history of CNS involvement (HR 8.37; 95% CI, 3.04-23.04; P < 0.01), and axi-cel (HR, 4.56; 95% CI, 1.88-11.09; P < 0.01) as independent risk factors. Patients divided by the median reticulocyte count at infusion (2.57 × 104/μL) demonstrated significantly higher 30-day cumulative incidence of ICANS in those with lower counts (25.5% versus 7.8% at 30 days; P = 0.018).

CONCLUSION:

Reticulocyte counts at infusion, a simple hematological parameter, may help predict ICANS development and guide optimal risk-based management of chimeric antigen receptor (CAR)-T cell therapy.

01 May 2026·Blood neoplasia

Impact of age on outcomes after CD19 CAR T-cell therapy for large B-cell lymphomas

Article

Author: Foss, Francine ; Wudhikarn, Kitsada ; Grover, Natalie S ; Hosing, Chitra ; Hashmi, Shahrukh ; Salas, María Queralt ; Dahiya, Saurabh ; Woolfrey, Ann ; Kharfan-Dabaja, Mohamed A ; Shouse, Geoffrey ; Hildebrandt, Gerhard C ; Yared, Jean A ; Moskop, Amy ; Kim, Soyoung ; Abid, Muhammad Bilal ; Afrough, Aimaz ; Hill, John M ; Ganguly, Siddhartha ; Deol, Abhinav ; Epperla, Narendranath ; Hossain, Nasheed M ; Hematti, Peiman ; Murthy, Hemant S ; Pasquini, Marcelo C ; Bhatt, Vijaya Raj ; Turtle, Cameron J ; Ahmed, Sairah ; Hashmi, Hamza ; Johnson, P Connor ; Mirza, Abu-Sayeef ; Krem, Maxwell M ; Thakar, Monica S ; Maziarz, Richard T ; Barba, Pere ; Riedell, Peter A ; Ibrahim, Uroosa ; Lekakis, Lazaros J ; Oloyede, Temitope ; Badar, Talha ; Strouse, Christopher ; Gowda, Lohith ; Brown, Valerie I

Age may influence clinical outcomes after CD19-directed chimeric antigen receptor (CAR) T-cell (CAR-T) therapy. Real-world data on the survival and toxicity outcomes of older patients receiving CAR-T therapy are limited. We used data from the Center for International Blood and Marrow Transplant Research for adults with diffuse large B-cell lymphoma who received CAR-T therapy from May 2018 to June 2020. Cumulative incidence and severity of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were reported. Efficacy and safety outcomes were assessed using age as a continuous variable and among 4 age groups: 18 to 54, 55 to 64, 65 to 74, and ≥75 years. Nearly half (44%) of 1916 total recipients were aged ≥65 years. Patients received either axicabtagene ciloleucel (75%) or tisagenlecleucel (25%). Overall rates of CRS and ICANS were 75% and 43%, and severe rates of CRS and ICANS were 9% and 21%, respectively. For all patients, 12-month overall survival (OS), progression-free survival (PFS), and relapse rates were 62%, 42%, and 55%, respectively. As a continuous variable, older age did not affect OS, PFS, and CRS; however, the risk of ICANS increased with age (hazard ratio [HR], 1.03; P < .001). At age >64 years, risk for ICANS increases (HR, 1.65;95% confidence interval (CI), 1.33-2.1; P < .001). In a categorical analysis, the 65 to 74-year age group had lower relapse risk (HR, 0.77;95% CI, 0.64-0.93; P = .005) than younger patients. CD19 CAR-T therapy is effective for older adults, and older age does not worsen mortality. Older age is associated with higher ICANS risk and should guide patient selection.

299

News (Medical) associated with Tisagenlecleucel

21 Apr 2026

·www.prnewswire.com

Verismo Therapeutics Presents Preclinical Data at AACR 2026 for SynKIR™-310 KIR-CAR Indicating Superior Preclinical Activity in B Cell Malignancies and Early Clinical Efficacy

Preclinical data showed enhanced anti-tumor activity and reduced cytokine release compared to conventional single-chain CAR T approaches Early clinical case from CELESTIAL-301 trial, the first-in-human KIR-CAR clinical trial in patients with relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL), illustrates an ongoing complete patient response after 6 months SynKIR™-310 KIR-CAR is a potential first-of-its-kind multi-chain KIR-CAR living medicine designed with natural 'on-off' switch mechanism, which may limit T cell exhaustion PHILADELPHIA, April 21, 2026 /PRNewswire/ -- Verismo Therapeutics, a clinical-stage CAR T cell therapy company pioneering a novel multi-chain KIR-CAR platform technology, today announced new preclinical in vivo data for SynKIR™-310 KIR-CAR living medicine, highlighting KIR-CAR's superior anti-tumor activity and improved cytokine profile compared to conventional single-chain CAR T in B cell malignancies. Early clinical data for SynKIR™-310 KIR-CAR were also announced from a multi-site Phase 1 clinical trial, CELESTIAL-301 (NCT06544265) for patients with B cell lymphomas, highlighting a patient's ongoing complete response after 6 months. These data were presented on April 21 at the American Association for Cancer Research (AACR) Annual Meeting 2026 in San Diego, CA (Poster Number: 5193). "While single-chain CAR T therapies have revolutionized blood cancer treatment, nearly half of blood cancer patients who initially respond relapse as early as six months after treatment,[1]" said Laura A. Johnson, Ph.D., Chief Scientific Officer and Chief Operating Officer of Verismo Therapeutics. "This urgent patient need is precisely why we designed multi-chain SynKIR™-310 KIR-CAR with a natural 'on-off' switch to potentially address chronic T cell exhaustion and increase durability. "We are excited to report new preclinical data showing SynKIR™-310 KIR-CAR improved anti-tumor activity with reduced cytokine production compared to a conventional single-chain CAR T approach. We're also encouraged that early clinical observation of one patient in our CELESTIAL-301 trial achieved a complete tumor response that remains ongoing beyond six months. Together, these data support continued clinical evaluation of the KIR-CAR platform and SynKIR™-310, specifically in patients with relapsed or refractory B cell malignancies, including follicular lymphoma." These preclinical data were shared during poster session "Adoptive Cell Therapy 2" by Megan Blair, Ph.D., In Vivo Lead at Verismo Therapeutics, on April 21, showing multi-chain SynKIR™-310 KIR-CAR had enhanced anti-tumor activity in vivo compared to tisagenlecleucel and axicabtagene ciloleucel analogs, in B-NHL xenograft mouse models, with reduced cytokine production, while maintaining comparable T cell persistence. These findings suggest a potential favorable benefit-risk profile of multi-chain KIR-CAR compared to traditional single-chain CAR T. Early clinical data from CELESTIAL-301 were also shared, highlighting treatment of a 70-year-old male patient with follicular lymphoma who received SynKIR™-310 KIR-CAR at the lowest dose level (DL1) and achieved complete tumor response 28 days later, which remains ongoing as of their most recent 6-month follow-up appointment. The CELESTIAL-301 trial is supported in part by the Institute for Follicular Lymphoma Innovation (IFLI), a global non-profit private foundation dedicated to accelerating the development of innovative treatment options for patients with follicular lymphoma, which has committed up to $4.05 million to advance SynKIR™-310 KIR-CAR development in follicular lymphoma (FL) and expand patient enrollment in the trial. "IFLI invested in SynKIR™-310 because we believe its novel KIR-CAR architecture has the potential to meaningfully change the treatment trajectory for patients with follicular lymphoma who have exhausted standard options, including prior CAR T therapy," said David McCullagh, IFLI Managing Director. "Today's data provide an important early signal supporting the potential of this platform. We look forward to continuing to support Verismo as they advance SynKIR™-310 KIR-CAR toward broader clinical development in FL, along with other B cell malignancies." About SynKIR™-310 KIR-CAR and the CELESTIAL-301 Clinical Trial SynKIR™-310 is an investigational autologous engineered cell therapy developed using Verismo's KIR-CAR platform. This approach utilizes a multi-chain, split-signaling architecture derived from natural killer cells, designed to drive long-term anti-tumor T cell function without T cell exhaustion. By keeping antigen recognition separate from T cell activation, the multi-chain architecture is intended to sustain T cell activity to provide a more durable response compared to single-chain CAR T approaches. CELESTIAL-301 is a Phase 1 first-in-human, multi-center, open-label, basket clinical trial, evaluating SynKIR™-310 KIR-CAR in patients with relapsed/refractory B-NHL, such as FL, and including those who have or have not previously received CD19 CAR T therapies. See clinicaltrials.gov (NCT06544265) for more information. About Verismo Therapeutics Verismo Therapeutics, a subsidiary of HLB Innovation, is a pioneer in multi-chain KIR-CAR technology, with assets SynKIR™-110 ( NCT05568680) and SynKIR™-310 ( NCT06544265) currently in Phase 1 clinical trials. Verismo is the only company developing the KIR-CAR platform, using a modified NK cell-derived receptor and DAP12 pairing, designed to improve T cell functional persistence and reduce exhaustion, resulting in improved efficacy against challenging tumors. The KIR-CAR platform technology was developed specifically to address areas of high unmet medical need, including advanced solid tumors and B cell associated disorders and malignancies. For more information, visit: About the KIR-CAR Platform The KIR-CAR platform is a multi-chain T cell therapy that has shown to be a highly effective solid tumor treatment in otherwise CAR-resistant animal models with hard-to-treat tumors. Using NK cell-derived killer immunoglobulin-like receptor (KIR) and DAP12 to split the target binding and T cell activation signals provides a novel paired immune-receptor activation that is independent from CD3 signaling, and works independent of co-stimulation. KIR-CAR enables sustained cell receptor expression in T cells, and induces deeper, more durable tumor treatments. Together, our multi-chain cell signaling platform provides the potential to deliver effective patient treatments by eliminating the constant background signaling and early T cell exhaustion observed in conventional single-chain CAR T therapy, with potential to treat both solid and hematologic tumors. Forward Looking Statements This press release contains forward-looking statements, including, but are not limited to, those statements regarding our expectations for the timing, progress, and results of clinical trials; potential regulatory approvals; anticipated benefits, safety, and efficacy of our product candidates; our product development strategies; and other statements that are not historical facts. These forward-looking statements are based on our current expectations and are subject to numerous risks and uncertainties that could cause actual outcomes to differ materially. Important factors that could cause actual results to differ include, among others, risks related to clinical trials, regulatory processes, market acceptance, financial projections, and our ability to successfully develop and commercialize our product candidates. Forward-looking statements in this release represent our beliefs and assumptions only as of the date hereof, and we expressly disclaim any obligation to update these statements as new information becomes available, except as required by law. 1 Bachy, E., Le Gouill, S., Di Blasi, R., Sesques, P., Manson, G., Cartron, G., Beauvais, D., Roulin, L., Gros, F. X., Rubio, M. T., Bories, P., Bay, J. O., Llorente, C. C., Choquet, S., Casasnovas, R.-O., Mohty, M., Guidez, S., Joris, M., Loschi, M., & Carras, S. (2022). A real-world comparison of tisagenlecleucel and axicabtagene ciloleucel CAR T cells in relapsed or refractory diffuse large B cell lymphoma. Nature Medicine, 1–10. Investor Relations: Pavel Aprelev, Ph.D. Verismo Therapeutics [email protected] Media Contact: Peter Collins TogoRun [email protected] 908-499-1200 SOURCE Verismo Therapeutics 21% more press release views with Request a Demo

Cell TherapyPhase 1AACRImmunotherapyClinical Result

14 Apr 2026

·allsci.com

BioOra and Cincinnati Children’s advance Atla-cel CAR-T therapy in pediatric B-cell acute lymphoblastic leukaemia

Atla-cel, an autologous CD19-directed CAR-T cell therapy developed by BioOra, is moving into pediatric clinical development after BioOra entered a strategic collaboration with Cincinnati Children’s Hospital Medical Center to evaluate the therapy in children and adolescents with relapsed or refractory B-cell acute lymphoblastic leukemia. Cincinnati Children’s will lead and manage a global clinical programme enrolling patients across the US, New Zealand, and potentially Australia. The collaboration builds on adult clinical data from BioOra’s ENABLE trial program, conducted with the Malaghan Institute of Medical Research in New Zealand. Financial terms were not disclosed, consistent with an academic-industry clinical collaboration in which BioOra retains IP, manufacturing, and commercial rights while Cincinnati Children’s contributes clinical infrastructure and trial management. Deal context Atla-cel (atlacabtagene autoleucel; pINN List 134) is a third-generation, autologous CAR-T therapy directed at CD19, a surface antigen expressed on malignant B cells. CD19-targeted CAR-T therapies are an established therapeutic class — Novartis’s tisagenlecleucel was the first approved in paediatric B-ALL — but BioOra describes Atla-cel as incorporating design advances intended to improve anti-tumour activity and tolerability relative to earlier-generation constructs. That characterization is sourced from company materials and has not been independently validated in a randomized comparison. Results from the Phase I ENABLE-1 study in adults with relapsed or refractory lymphoma, presented at the 2024 American Society of Hematology Annual Meeting, showed complete response rates alongside low rates of serious cytokine release syndrome and markedly reduced immune effector cell-associated neurotoxicity syndrome, or ICANS. In paediatric patients, ICANS carries heightened concern given the vulnerability of the developing brain to immune-mediated injury, and the observed adult safety signals form the primary scientific rationale for pediatric investigation. Atla-cel is manufactured using the Cocoon automated closed-system platform, developed by Lonza and deployed at BioOra’s purpose-built GMP facility in Christchurch, New Zealand. The Cocoon system integrates T cell enrichment, activation, viral transduction, and expansion within a single-use, functionally closed cassette, reducing operator handling and enabling operation in lower-grade cleanroom environments. BioOra’s strategic positioning centres on this decentralised manufacturing model as a logistical and accessibility advantage over the centralised approaches used by first-generation approved CAR-T products. The proposed pediatric program will be led by Stella M. Davies of Cincinnati Children’s, a recognised specialist in pediatric hematology-oncology and hematopoietic cell transplantation. As part of the collaboration, Cincinnati Children’s president and CEO Steve Davis joins the BioOra board of directors. Separately, Atla-cel is in a Phase II ENABLE-2 registration trial in adults with relapsed or refractory B-cell lymphoma, which BioOra is advancing independently. The pediatric B-ALL indication targeted here is the same as that approved for tisagenlecleucel, but BioOra’s commercial differentiation rests on its Cocoon-based manufacturing model and the ICANS signal from ENABLE-1 rather than on target novelty. Whether that safety profile holds in a pediatric population remains the central clinical question the Cincinnati Children’s-led programme is designed to answer. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

13 Apr 2026

·www.fiercebiotech.com

Allogene’s off-the-shelf CAR-T erases lingering lymphoma cells in early slice of data

The 41.6% difference in MRD eradication between the cema-cel and control arms easily tops the 25% to 30% benchmark that is considered clinically meaningful.\n Allogene Therapeutics’ gamble on a never-before-seen trial strategy seems to be paying off, with the biotech’s off-the-shelf cell therapy eradicating residual lymphoma in over half of evaluated patients in the study’s first data drop.The small slice of data includes 24 patients out of a planned enrollment of around 220 for the phase 2 ALPHA3 trial, all of whom still had minimal residual disease (MRD) following six first-line rounds of chemotherapy. Seven of the 12 patients given Allogene’s donor-derived CAR-T therapy cema-cel tested negative for MRD at day 45, compared to two of 12 patients in the control arm.The 41.6% difference in MRD eradication between the cema-cel and control arms exceeded the 25% to 30% benchmark that is considered clinically meaningful, Allogene said in an April 13 release.At that same 45-day time point, cema-cel treatment reduced circulating lymphoma DNA in the blood by an average of 97.7%, compared to a 26.6% increase in the control arm, Allogene announced. The Bay Area biotech noted that cema-cel did not result in any cases of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, which are common side effects of traditional autologous CAR-Ts that use T cells engineered from the patient\'s own cells. As a result, 10 of the 12 cema-cel patients were managed entirely in outpatient centers after treatment, while the other two needed hospitalization for heart-related medical conditions unrelated to the cell therapy.“Our goal has always been to move CAR-T from a bespoke procedure available at a limited number of centers to a scalable therapy that can reach patients more broadly,” Allogene CEO David Chang, M.D., Ph.D., said in the release. “Although still early, the ALPHA3 results show encouraging MRD clearance and a favorable safety profile.”Allogene expects enrollment for the trial to wrap up by the end of 2027, according to the release, with many more important data drops to come. Most importantly, the biotech needs to demonstrate that destroying residual disease actually prevents relapse. Key data on event-free survival is expected in mid-2027 and mid-2028. Should Allogene succeed, it would then file for approval, and cema-cel could ultimately become the first donor-derived CAR-T therapy to get the FDA’s blessing.“We see today’s data as extremely positive and believe the 41.6-percentage-point difference in MRD-clearance de-risks the primary [event-free survival] endpoint of the study,” analysts from William Blair wrote in an April 13 note. “We therefore have increased confidence in the overall success of ALPHA3 and continue to believe cema-cel has the potential to leapfrog autologous CD19 CAR-T therapies approved in the second-line setting.” MRD has become a hot topic in oncology, as techniques for detecting the few cancer cells that can linger in the body after treatment have been rapidly approved. “MRD itself has been a concept that\'s been around for a long, long time and has been used to make clinical decisions in other heme malignancies, but it hadn\'t been used effectively in lymphoma,” Allogene’s Chief Medical Officer Zachary Roberts, M.D., Ph.D., told Fierce ahead of the ALPHA3 data drop. That started to change around 2022 and 2023, he said, when evidence emerged that a positive MRD test after treatment—even though a patient may otherwise seem to have no more lymphoma—was a strong predictor of relapse.This prognostic power, coupled with competition from approved autologous CAR-Ts in late-line lymphoma, such as Kite’s Yescarta and Tecartus, Novartis’ Kymriah and Bristol Myers Squibb’s Breyanzi, prompted Allogene to make a bold play at the beginning of 2024.The company halted its pivotal phase 2 studies, the first in the donor-derived or allogeneic CAR-T field, to launch a new trial based on the theory that cema-cel could eliminate MRD after initial chemotherapy and render the need for subsequent lines of treatment moot.Should ALPHA3 ultimately succeed, it would change the way lymphoma is treated entirely, Roberts said. At the moment, MRD isn’t routinely tested in lymphoma patients because even if there’s a positive result, there’s not much doctors can do except observe the patient and hope the disease doesn’t come back.The most important thing that will “propel MRD into a standard of care” is if oncologists “have something to do with a positive result,” Roberts said.“The only clinical trial that\'s being run today that is designed to answer that question is ALPHA3,” he said. And because it is available off-the-shelf, cema-cel is the perfect product for the job, Roberts claimed.Allogene’s cema-cel data comes at a critical time for the field of allogeneic CAR-T, which has struggled to secure FDA approval even as traditional autologous approaches rapidly improve and next-gen in vivo techniques gain steam. The slow pace of progress has led to waning investor interest, leading some in the field to declare that allogeneic CAR-T is suffering a “nuclear winter.”For Allogene, this morning\'s initial ALPHA3 data is a sign that a thaw may be on the way. A win for cema-cel could make others who had long given up on the allo approach take another look, Roberts suggested to Fierce.“Winter always comes before spring,” he added. “These are the first little green shoots we\'re seeing.”Editor\'s note: This story was updated at 1:00 p.m. ET with analyst commentary.

100 Deals associated with Tisagenlecleucel

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Tisagenlecleucel	L01	DB13881

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent B Acute Lymphoblastic Leukemia	South Korea	Novartis AG	05 Mar 2021
Refractory B Acute Lymphoblastic Leukemia	South Korea	Novartis AG	05 Mar 2021
CD19-positive B-cell acute lymphoblastic leukemia	Japan	Novartis Pharma KK	01 May 2019
Follicular Lymphoma	Canada	Novartis Pharmaceuticals Canada, Inc.	05 Sep 2018
Acute Lymphoblastic Leukemia	European Union	Novartis Europharm Ltd.	23 Aug 2018
Acute Lymphoblastic Leukemia	Iceland	Novartis Europharm Ltd.	23 Aug 2018
Acute Lymphoblastic Leukemia	Liechtenstein	Novartis Europharm Ltd.	23 Aug 2018
Acute Lymphoblastic Leukemia	Norway	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma recurrent	European Union	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma recurrent	Iceland	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma recurrent	Liechtenstein	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma recurrent	Norway	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma refractory	European Union	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma refractory	Iceland	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma refractory	Liechtenstein	Novartis Europharm Ltd.	23 Aug 2018
Diffuse large B-cell lymphoma refractory	Norway	Novartis Europharm Ltd.	23 Aug 2018
Recurrent Follicular Lymphoma	European Union	Novartis Europharm Ltd.	23 Aug 2018
Recurrent Follicular Lymphoma	Iceland	Novartis Europharm Ltd.	23 Aug 2018
Recurrent Follicular Lymphoma	Liechtenstein	Novartis Europharm Ltd.	23 Aug 2018
Recurrent Follicular Lymphoma	Norway	Novartis Europharm Ltd.	23 Aug 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Novartis Pharmaceuticals Corp.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	China Novartis Institutes for BioMedical Research Co., Ltd.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	United States	Novartis Pharma AG	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Japan	Novartis Pharma AG	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Japan	Novartis Pharmaceuticals Corp.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Japan	China Novartis Institutes for BioMedical Research Co., Ltd.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Australia	Novartis Pharmaceuticals Corp.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Australia	China Novartis Institutes for BioMedical Research Co., Ltd.	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Australia	Novartis Pharma AG	07 May 2019
Aggressive B-Cell Non-Hodgkin Lymphoma	Phase 3	Austria	China Novartis Institutes for BioMedical Research Co., Ltd.	07 May 2019

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Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Non-Hodgkin Lymphoma	601	Axicabtagene ciloleucel (axi-cel)	fixbaretdh(rybgfbazix) = qphbpvvdjm fsmyjulmnl (jliivmtbtz ) View more	Positive	04 Feb 2026
				Lisocabtagene maraleucel (liso-cel)	fixbaretdh(rybgfbazix) = mjcqlfewgl fsmyjulmnl (jliivmtbtz ) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	B-Cell Lymphoma	235	Axicabtagene ciloleucel (Yescarta)	lkebkmstgy(wscpwhprmp) = sqfimzzbib yocaydtyrz (rendldxyjw, 14.2 - 14.61) View more	Positive	04 Feb 2026
				Brexucabtagene autoleucel (Tecartus)	lkebkmstgy(wscpwhprmp) = usikakewki yocaydtyrz (rendldxyjw, 14.79 - 16.46) View more
Tandem Meetings ASTCT and CIBMTR2026	Not Applicable	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma CXCL9 \| IL-18 \| SC5b-9	12	Tisagenlecleucel	dxokahlizb(skggyqwoda) = llgpcmokng crjprkfcuw (mbhgzissrd ) View more	Positive	04 Feb 2026
NCT05460533 (REFUEL, Tandem Meetings ASTCT and CIBMTR2026)	Phase 2	CD19-positive B-cell acute lymphoblastic leukemia CD19-Positive	30	Tisagenlecleucel	lmhhkjkuzh(agfqsmawlx) = tciszqchvk cmunassbdy (npjczsjetr ) View more	Negative	04 Feb 2026
NCT03642626 (MT2017-45, CTgov)	Phase 2	Philadelphia positive acute lymphocytic leukaemia \| Large B-cell lymphoma \| Acute Lymphoblastic Leukemia ... View more	150	YESCARTA+Fludarabine+Cyclophosphamide (ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL))	mrrqanbdnz = tcgdrihehw iovkbwbrhw (bfnarudiav, flbjbfjnlh - bjpnrssums) View more	-	23 Jan 2026
				Fludarabine+Cyclophosphamide+KYMRIAH (ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL))	mrrqanbdnz = jfwtpfkhkp iovkbwbrhw (bfnarudiav, ejbysnmjbq - grxpzrlnrx) View more
ASH2025	Not Applicable	Diffuse Large B-Cell Lymphoma	1,022	Axicabtagene Ciloleucel	atqlmtzhpm(xdzagkecbg) = vrqloacyax cykwldlonb (hlwwearonh, 23 - 34) View more	Negative	06 Dec 2025
				Glofitamab	atqlmtzhpm(xdzagkecbg) = chixygitch cykwldlonb (hlwwearonh, 11 - 22) View more
ASH2025	Not Applicable	Large B-cell lymphoma \| Mantle-Cell Lymphoma \| Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	430	Immunoglobulin replacement therapy (IGRT)	lsvjshxlkp(mrmhlhxkmd) = Infection was probable in 43 (18.1%). Of episodes with a pathogen identified, 58.3% were viral, 40.7% bacterial, 0.5% fungal and 0.5% other. The primary focus was respiratory in 75%. Infection was grade ≥3 in 44% including grade 5 in 6.8%. zippyzxxtb (tkybllgsxa ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Diffuse large B-cell lymphoma recurrent	632	Tisagenlecleucel (tisa-cel)	otluabkuew(zhdyjmilcw) = lxfxqrixjr tqbtldovyk (lcttzucihe ) View more	Positive	06 Dec 2025
				Axicabtagene ciloleucel (axi-cel)	otluabkuew(zhdyjmilcw) = lnbdkbwrxp tqbtldovyk (lcttzucihe ) View more
ASH2025	Not Applicable	Secondary Central Nervous System Lymphoma	62	axicabtagene ciloleucel	pzcxytkeic(ijxbxawlfh) = qwtvvcwmtg gntsjamuhm (kbxgrofqxe ) View more	Positive	06 Dec 2025
				tisagenlecleucel	pzcxytkeic(ijxbxawlfh) = wtqjfndiyw gntsjamuhm (kbxgrofqxe ) View more
ASH2025	Not Applicable	Recurrent Childhood Acute Lymphoblastic Leukemia	34	fludarabine (LOW FLU AUC (<18.5 mg·hr/L))	maayyvuhnm(jnzykxshui) = qvbotjccux eemobjpemr (rsinvpbqlb, 44 - 80) View more	Positive	06 Dec 2025
				fludarabine (OPTIMAL FLU AUC (18.5-21.7))	dyydxpract(jaxstxdwgp) = qswratffta tncyqjiuhk (nbtaupnxoi, 100 - 100) View more