Delving into the Latest Updates on Lisocabtagene maraleucel with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

anti-CD19-EGFRt-4-1BB-zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, anti-CD19/EGFRt/4-1BB/zeta modified CAR CD8+ and CD4+ T lymphocyte therapy, CD19-directed chimeric antigen receptor T cell therapy

+ [7]

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

Mantle cell lymphoma recurrentMantle cell lymphoma refractoryMarginal zone lymphoma recurrent+ [27]

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaB-Cell Malignant NeoplasmPrecursor B-Cell Lymphoblastic Leukemia-Lymphoma+ [3]

Originator Organization

Fred Hutchinson Cancer Research Center

Bristol Myers Squibb Co.

Active Organization

Bristol-Myers Squibb Pharma EEIG

Celgene Corp.

Juno Therapeutics, Inc.

+ [3]

Inactive Organization-

License Organization

Fred Hutchinson Cancer Research Center

Juno Therapeutics, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (05 Feb 2021),

Diffuse Large B-Cell LymphomaFollicular LymphomaHigh grade B-cell lymphoma+ [1]

RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union)

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Structure/Sequence

Sequence Code 133531

Source: *****

Sequence Code 133534

Source: *****

Sequence Code 133555

Source: *****

Sequence Code 133567

Source: *****

Sequence Code 133586

Source: *****

Sequence Code 171111

Source: *****

The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed/refractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are:
* How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone?
* How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more?
* How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.

Start Date14 Oct 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07194980

/ RecruitingPhase 2

Safety and Efficacy of the Addition of Nemtabrutinib to Lisocabtagene Maraleucel in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia

This phase II trial studies how well the addition of nemtabrutinib to lisocabtagene maraleucel in treating patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). Nemtabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lisocabtagene maraleucel is a type of treatment called chimeric antigen receptor (CAR) T-cell therapy, in which a patient's T-cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T-cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T-cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T-cells are grown in the laboratory and given to the patient by infusion for treatment. Adding nemtabrutinib to lisocabtagene maraleucel may be an effective treatment for relapsed/refractory CLL/SLL.

Start Date01 Sep 2026

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT07725406

/ Not yet recruitingPhase 1IIT

A Phase Ib, Dose-Escalation Study of Augmented Lymphodepletion and CAR T-cell Priming With Low-dose Total Body Irradiation in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphomas and Multiple Myeloma Receiving Treatment With Commercial CD19 or BCMA-directed CAR T-cell Therapies

This is a clinical trial to evaluate the safety of combining CAR T-cell therapy with low-dose total body irradiation (LD-TBI) in patients with previously treated large B-cell lymphoma (LBCL) or multiple myeloma (MM). The investigators' hypothesis is that the combination will make the immune system more active in fighting cancer by increasing the display of antigens and activating pathways that lead to cell death, including death receptors like FAS and TRAIL2. This approach is expected to help the CAR T cells grow and last longer, leading to stronger anti-tumor effects and more cancer cell deaths. Participants will receive LDTBI treatment before their CAR T cell therapy and will be followed up for 2 years.

Start Date01 Aug 2026

Sponsor / Collaborator

Weill Medical College of Cornell University

100 Clinical Results associated with Lisocabtagene maraleucel

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100 Translational Medicine associated with Lisocabtagene maraleucel

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100 Patents (Medical) associated with Lisocabtagene maraleucel

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239

Literatures (Medical) associated with Lisocabtagene maraleucel

01 Aug 2026·Transplantation and Cellular Therapy

Prolonged Cytokine Release Syndrome is Associated with Hypofibrinogenemia after CD19-Directed CAR T-Cell Therapy in Adult Patients with Relapsed/Refractory Lymphoma

Article

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

CD19-directed chimeric antigen receptor (CAR) T-cell therapy has markedly improved outcomes for patients with relapsed or refractory B-cell malignancies, although coagulopathy characterized by hypofibrinogenemia has increasingly been recognized as a complication after CAR T-cell therapy. Nevertheless, its contemporary real-world incidence, risk factors, and clinical impact remain incompletely defined. This study aimed to determine the real-world incidence, risk factors, and clinical impact of hypofibrinogenemia following CD19-directed CAR T-cell therapy for relapsed or refractory B-cell lymphoma. This retrospective cohort study included all consecutive adult patients (≥16 years) with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL) who received tisagenlecleucel (tisa-cel), lisocabtagene maraleucel (liso-cel), or axicabtagene ciloleucel (axi-cel) at Kyoto University Hospital between December 2019 and December 2024. We also evaluated detailed CRS severity according to modified CRS grading (m-CRS), in which grade 1 was subdivided into grade 1a (duration of CRS-related symptoms ≤5 days) and grade 1b (duration of CRS-related symptoms >5 days), as previously described; grade 1b CRS was defined as "prolonged CRS." A total of 111 patients (74 tisagenlecleucel [tisa-cel] [67%], 24 lisocabtagene maraleucel [liso-cel] [22%], and 13 axicabtagene ciloleucel [axi-cel] [12%]) were included. Hypofibrinogenemia (fibrinogen ≤150 mg/dL) was observed in 28 patients (25%) within 30 days after infusion (median onset, 10.5 days). FFP was administered to 15 patients (14%). Multivariable analysis revealed that grade ≥1b CRS (adjusted hazard ratio [aHR], 4.59; 95% confidence interval [CI], 1.89 to 11.14; P < .01), lower baseline fibrinogen levels (aHR, 1.07 per 10 mg/dL decrease; 95% CI, 1.02 to 1.14; P = .01), and axi-cel use (versus tisa-cel: aHR, 3.29; 95% CI, 1.38 to 7.83; P < .01) were independently associated with hypofibrinogenemia. In our cohort, no fatal bleeding events occurred. Hypofibrinogenemia was not associated with inferior overall survival or progression-free survival. Prolonged CRS (grade 1b) or grade ≥2 CRS, lower baseline fibrinogen, and use of axi-cel were independently associated with hypofibrinogenemia. Risk-adapted fibrinogen monitoring may help identify patients who could benefit from closer surveillance, and timely fibrinogen replacement may optimize supportive care. Further multicenter studies are warranted to validate these findings and clarify the clinical impact of hypofibrinogenemia, including hemorrhagic outcomes.

01 Aug 2026·JOURNAL OF PHARMACEUTICAL SCIENCES

Delay differential equation (DDE) modeling of CAR-T cellular kinetics: Application to BCMA-targeted (Ide-cel, Orva-cel) and CD19-targeted (Lisocel) therapies

Article

Author: Cheng, Yiming ; Li, Yan

Chimeric antigen receptor (CAR) T-cell therapies undergo rapid in vivo expansion followed by contraction and variable long-term persistence after a single infusion, yielding cellular kinetic (CK) profiles that differ fundamentally from conventional small-molecule and biologic pharmacokinetics. Piecewise, phase-based CK models are widely used, but discontinuous switching and constant expansion assumptions can create numerical instability around the transition window and bias the characterization of early expansion and near-peak behavior. Building on our prior saturable expansion framework (Vmax/Km), we advanced CAR-T CK modeling by introducing (i) smooth S-shaped gating to replace discontinuous phase switching and enable continuous time-varying expansion dynamics, and (ii) delay differential equation (DDE) components to evaluate whether longitudinal data support explicit lags in downstream biological processes. Data were pooled from three CAR-T trials (TRANSCEND, KarMMa-3, and EVOLVE) spanning two BCMA-targeted products (ide-cel, orva-cel) and one CD19-targeted product (lisocel). Models were estimated in Monolix using SAEM with importance sampling for final likelihood evaluation. Model selection relied on likelihood-based criteria (AIC, BIC, and Monolix BICc) and diagnostic assessments. Relative to a constant-expansion baseline, saturable expansion improved fit and reduced systematic model misspecification at high transgene levels (e.g., qPCR transgene copies/µg). Among multiple DDE placements evaluated, the data most strongly supported a delay on effector-to-memory conversion; delays in effector-like and/or memory-like decay were not favored. Simulations indicated that the conversion delay primarily modulated the timing and magnitude of the memory-like trajectory, with minimal impact on total-cell trajectories during the expansion phase at the evaluated scale. In a shared covariate framework with product as a categorical effect, BCMA-targeted products exhibited higher baseline levels and expansion capacity than lisocel, with stronger evidence for slower effector-like decay for orva-cel than ide-cel. Overall, smooth-gated saturable expansion with DDE-based delayed conversion provides a parsimonious, biologically motivated framework for CAR-T CK and supports cross-product comparisons under harmonized structural assumptions.

16 Jul 2026·BLOOD

Real-world outcomes for lisocabtagene maraleucel in patients with relapsed or refractory large B-cell lymphoma

Article

Author: Dahiya, Saurabh ; Egini, Ogechukwu ; Patel, Sagar S. ; Bernasconi, David ; Reagan, Patrick M. ; Isufi, Iris ; Hamadani, Mehdi ; Ahmed, Sairah ; Kim, Soyoung ; Patel, Krish ; Lee, Dasom C. ; Kallam, Avyakta ; Liu, Fei Fei ; Frigault, Matthew J. ; Pasquini, Marcelo C. ; Crombie, Jennifer L. ; Palomba, M. Lia ; Mirza, Abu-Sayeef ; Lee, Catherine J. ; Odstrcil Bobillo, Maria Silvina ; Lunning, Matthew ; Thiruvengadam, Swetha Kambhampati ; Herrera, Alex F. ; Shadman, Mazyar ; Roy, Debasmita ; Hunter, Bradley D.

Abstract:

This study assessed real-world effectiveness and safety of lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), including those with high-risk disease, secondary central nervous system (sCNS) involvement, comorbidities, and poor fitness, using data in the Center for International Blood and Marrow Transplant Research Registry from 5 February 2021 to 4 February 2025. Eligible patients (N = 1116) received liso-cel and had ≥1 effectiveness and safety assessment after infusion, including 195 in the second-line setting, 71 with sCNS, and 257 with transformed LBCL. Median age was 71.1 years (range, 21.5-91.2), with 72.3% aged ≥65 years. Within the overall population, 6.6% had an Eastern Cooperative Oncology Group performance status of ≥2, 53.4% had ≥1 comorbidity, and the median number of previous lines of therapy was 3 (range, 1-16). Median study follow-up was 12.6 months (95% confidence interval [CI], 12.5-12.8). Among effectiveness-evaluable patients (n = 1109), objective response rate was 81.2% and complete response rate was 71.3%. Duration of response, progression-free survival, and overall survival rates at 12 months were 60.2% (95% CI, 56.4-63.9), 51.2% (95% CI, 48.0-54.4), and 67.6% (95% CI, 64.5-70.6), respectively. Cytokine release syndrome was reported in 51.0% of patients, with grade ≥3 events in 2.5%. Immune effector cell–associated neurotoxicity syndrome was reported in 26.6% of patients, with grade ≥3 events in 9.2%. The 12-month nonrelapse mortality rate was 6.1% (95% CI, 4.6-7.8). These real-world data reinforce the effectiveness and safety of liso-cel in this broad population of patients with R/R LBCL, including younger patients and those with high-risk disease features.

436

News (Medical) associated with Lisocabtagene maraleucel

18 Aug 2026

·www.biopharmadive.com

AstraZeneca scores in lung cancer; Sandoz inks a China deal

Today, a brief rundown of news involving AstraZeneca and a legal battle between Celgene shareholders and Bristol Myers Squibb, as well as updates from MapLight Therapeutics and Sandoz that you may have missed.A combination of AstraZenecas drug Tagrisso and Hutchmeds Orpathys helped people with a type of mutated lung cancer live longer than those given chemotherapy, the companies said Monday. The trial was in people with EGFR-positive non-small cell lung cancer that is driven by a mutation called MET whod already had their disease get worse after first- or second-line treatment with Tagrisso. The combination delayed disease progression or death compared with chemotherapy, as well as extending overall survival, the companies said. In a statement, Susan Galbraith, AstraZenecas executive vice president of oncology and hematology research, said the companies aim to deliver the first biomarker-directed, all-oral option in this setting to patients across the globe. Tagrisso is approved in the U.S. and other major jurisdictions, while Orpathys, which AstraZeneca is commercializing, is approved in China and Switzerland. Jonathan GardnerChinese pharmaceutical firm Shanghai Henlius Biotech announced Monday it inked a deal with Sandoz to license out three biosimilars in a pact worth as much as $232 million. Per the agreement, Sandoz is expected to pay just over $100 million in 2026 for near-copies of Eli Lillys Erbitux, or cetuximab; Amgens Repatha, or evolocumab; and GSKs Benlysta, or belimumab. Sandoz also acquired the option to license HLXTE-HAase1001, an experimental compound that Henlius said can convert time-consuming intravenous infusion into rapid subcutaneous injection. The Swiss generic drugmaker was the first to win approvalfor a biosimilar two decades ago as part of Novartis, and now makes roughly 1,300 medicines. Gwendolyn WuA federal appeals court resurrected a lawsuit by investors of Celgene against Bristol Myers Squibb over contingent payments promised under the two companies 2019 acquisition deal. The former Celgene investors, through their trustee, UMB Bank, have claimed Bristol Myers intentionally slowed development of the Celgene-developed cancer cell therapy Breyanzi to avoid paying out more than $6 billion due as part of a contingent value right that helped get the deal to completion. A federal district judge in 2024 ruled that UMB had been improperly appointed trustee, negating its claims. Appeals court Judge Beth Robinson last week ruled that because all parties to the agreement recognized UMB as the trustee, it had standing to sue. The case will now be sent back to the district court for further argument. Jonathan GardnerMapLight Therapeutics is considering partnerships as a path forward for one of its most advanced research projects. Tucked into the companys earnings report late last week was an update on ML-004, a drug designed to bind to serotonin receptors. ML-004 recently came up short in a mid-stage study focused on autism spectrum disorder, but MapLight still touts how it appeared safe and demonstrated clinically meaningful improvements in irritability. The company is now deciding what to do with the drug, with possible options including strategic collaborations, funding alternatives or both. Analysts havent attributed much of MapLights value to ML-004. At TD Cowen, for example, analyst Joseph Thome doesnt factor it into his model, viewing the program instead as an upside optionality. Jacob Bell '

AcquisitionDrug ApprovalCell Therapy

14 Aug 2026

·www.fiercepharma.com

It's BMS vs. Celgene investors once more after US appeals court revives lawsuit

A federal appeals court has overturned (PDF) the 2024 dismissal of a lawsuit filed by Celgene shareholders that accuses Bristol Myers Squibb of slow-walking the approval of blood cancer drug Breyanzi to avoid paying out a more than $6 billion contingent value rights (CVR) agreement. By a 3-0 vote, the U.S. Circuit Court of Appeals in Manhattan has ruled that District Judge Jesse Furman “erred in concluding” that Celgene’s trustee, UMB Bank, “lacked subject matter jurisdiction” to bring the lawsuit because of alleged defects in how Kansas City-based UMB was appointed to replace a prior trustee. “Even if UMB’s initial appointment as Trustee did not comport with the requirements of the CVR Agreement, UMB may maintain this suit because all parties to the Agreement, including Bristol-Myers, accepted UMB’s appointment as Trustee,” Judge Beth Robinson wrote in a decision this week, adding that BMS was not “confused about the status” of UMB as the representative of the shareholders. Twice in a span of 19 months, Furman dismissed the case. But in his ruling in October of 2024, he allowed that a separate breach-of-contract lawsuit could be refiled by a “properly appointed trustee.” In December of last year, Furman allowed part of that lawsuit to go forward. It is uncertain how this week’s appeals court decision will affect the breach of contract lawsuit. BMS did not respond immediately to a request for comment on either case. The lawsuits surround the 2019 acquisition of Celgene by BMS for $74 billion. The buyout included a CVR agreement under which BMS would pay Celgene investors $9 per share if three Celgene drugs received FDA approval by the end of 2020. Two of the drugs—Zeposia and Abecma—were approved by the FDA before their CVR deadlines passed. But Breyanzi’s nod came after its deadline, freeing BMS from paying what, at the time, amounted to $6.4 billion to Celgene investors. The FDA's original target decision date for Breyanzi’s approval was August 2020, but the U.S. endorsement didn’t come until February 5 of 2021. One reason for the delay was that BMS’ submission for approval was incomplete. Also at play were pandemic-related FDA inspection hurdles and an inspection failure at the facility of third-party manufacturer Lonza. UMB has argued that BMS excluded “critical and mandatory information in its initial filing” for Breyanzi and that the mistakes were intentional to delay the approval. The shareholders also accused BMS of failing to “take steps necessary to prepare” two manufacturing facilities for FDA inspections.

AcquisitionExecutive ChangePatent Infringement

14 Aug 2026

·firstwordpharma.com

BMS hit with Cytokinetics patent suit as Celgene investor case resurfaces

Bristol Myers Squibb is facing legal challenges on two fronts, with one targeting a patent tied to its first-in-class cardiac myosin inhibitor Camzyos (mavacamten) while the other revives a long-standing grievance brought by former Celgene shareholders.Cytokinetics on Thursday filed suit in US District Court for the District of Delaware against BMS and its MyoKardia subsidiary, which originally developed Camzyos, seeking a declaratory judgment that its own cardiac myosin inhibitor, Myqorzo (aficamten), doesn't infringe US Patent No. 12,616,697 and that the patent's claims are invalid.Pre-emptive strikeCytokinetics had flagged the issue as a litigation risk earlier this year in a regulatory filing. The '697 patent, which is held by MyoKardia, deals with an approach for treating patients with hypertrophic cardiomyopathy (HCM) or heart failure with preserved ejection fraction (HFpEF) who are already on beta blockers. According to Cytokinetics, it specifically covers the method for reducing or stopping the beta blocker therapy and replacing it with a myosin inhibitor. The company suggested BMS could argue that its method of using Myqorzo in HCM or HFpEF patients currently on beta blockers violates its patent.Myqorzo was approved last December for adults with symptomatic obstructive HCM, and competes directly with Camzyos (see – Spotlight On: Five key FDA approvals of 2025).Cytokinetics is also trying to expand its drug's reach, recently posting positive results for the non-obstructive form of the disease, whereas Camzyos failed a Phase III trial in that indication last year (see – Spotlight On: Cytokinetics could double Myqorzo's reach with non-obstructive HCM win and Physician Views Results: Cardiologists are cautiously optimistic about Cytokinetics' Myqorzo in non-obstructive HCM).The biotech is asking the Delaware court to prevent BMS and MyoKardia from threatening or bringing infringement claims against Cytokinetics or parties involved in the manufacture, sale or distribution of Myqorzo, saying it intends to "vigorously assert" its rights.Celgene CVRsMeanwhile, the US Court of Appeals for the Second Circuit on Thursday revived a multi-billion-dollar lawsuit stemming from BMS's acquisition of Celgene back in 2019.As part of that deal, Celgene shareholders had received contingent value rights (CVRs) that promised an additional $9 per share if BMS secured timely FDA approvals for three drugs: Breyanzi (lisocabtagene maraleucel), Zeposia (ozanimod) and Abecma (idecabtagene vicleucel). However, Breyanzi was approved five weeks after the relevant December 2020 deadline, causing the CVRs to expire without the potential $6.4 billion payout.The appeals ruling centred on whether UMB Bank, which CVR holders had appointed to replace an earlier trustee, had the right to bring the lawsuit. The court ruled that even if there were issues with how UMB was appointed, BMS had waived its right to challenge the appointment by knowingly accepting UMB as trustee and waiting more than two years to raise the objection.The decision breathes new life into a case that US District Judge Jesse Furman had thrown out in September 2024, though it's not yet clear what it means for a related lawsuit, one with several new claims against BMS, that Furman actually allowed to move forward last December.

Phase 3Drug ApprovalAcquisitionExecutive ChangeClinical Result

100 Deals associated with Lisocabtagene maraleucel

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KEGG	Wiki	ATC	Drug Bank
D11990	-	L01XX	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Mantle cell lymphoma recurrent	Japan	Bristol-Myers Squibb KK	25 Jul 2025
Mantle cell lymphoma refractory	Japan	Bristol-Myers Squibb KK	25 Jul 2025
Marginal zone lymphoma recurrent	Japan	Bristol-Myers Squibb KK	25 Jul 2025
Refractory Marginal Zone Lymphoma	Japan	Bristol-Myers Squibb KK	25 Jul 2025
Mantle-Cell Lymphoma	United States	Juno Therapeutics, Inc.	31 May 2024
Chronic Lymphocytic Leukemia	United States	Juno Therapeutics, Inc.	18 Mar 2024
Small Lymphocytic Lymphoma	United States	Juno Therapeutics, Inc.	18 Mar 2024
Recurrent Follicular Lymphoma	Japan	Bristol-Myers Squibb KK	20 Dec 2022
Refractory Follicular Lymphoma	Japan	Bristol-Myers Squibb KK	20 Dec 2022
Large B-cell lymphoma	Canada	Celgene, Inc.	06 May 2022
Diffuse large B-cell lymphoma recurrent	European Union	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	Iceland	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma recurrent	Norway	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma refractory	European Union	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma refractory	Iceland	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma refractory	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Diffuse large B-cell lymphoma refractory	Norway	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma recurrent	European Union	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022
Primary mediastinal large B-cell lymphoma recurrent	Iceland	Bristol-Myers Squibb Pharma EEIG	04 Apr 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic lymphocytic leukaemia refractory	NDA/BLA	United States	Bristol Myers Squibb Co.	18 Nov 2023
Recurrent Chronic Lymphoid Leukemia	NDA/BLA	United States	Bristol Myers Squibb Co.	18 Nov 2023
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	United States	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Japan	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Belgium	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Finland	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	France	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Germany	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Italy	Celgene Corp.	23 Oct 2018
Refractory Aggressive Non-Hodgkin Lymphoma	Phase 3	Netherlands	Celgene Corp.	23 Oct 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03575351 (ASCO2026)	Phase 1/2	Large B-cell lymphoma Second line	420	Liso-cel	lrkvwbjdbi(cbwplnzldx) = sbicdgsizw cfhhswyrms (zeuctppipn ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Chronic Lymphocytic Leukemia	45	Lisocabtagene maraleucel (liso-cel)	npwztjwwdu(umqgynxbso) = Among pts with any-grade (gr) cytokine release syndrome (80%; gr ≥ 3, 4%) or immune effector cell-associated neurotoxicity syndrome (36%; gr ≥ 3, 13%), no gr 5 events occurred. Clinically significant infections were reported in 40% of pts, and at 30 d after infusion, 18% had persistent gr 4 thrombocytopenia and/or neutropenia. Rates were low of HLH/MAS (7%), second primary malignancies (2%; 1 case of basal cell carcinoma 34 d postinfusion), tumor lysis syndrome (7%), and gr 3/4 organ toxicity (9%). vaxffzorhc (uhguxglkrd )	Positive	29 May 2026
NCT07015242 (CAROLYN, ASCO2026)	Phase 2	Primary Central Nervous System Lymphoma First line	65	Lisocabtagene maraleucel (liso-cel)	xpeuujybdd(nlodqaqcxr) = awyjvgoyrz rbvbbymhxf (pcfycprubd ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Hematologic Neoplasms	1,117	Cilta-cel	vnfnsekufp(smmkvexewa) = ciattldwhf vzdroiqfdb (rxonoawkol ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Hematologic Neoplasms	1,117	Ide-cel	vnfnsekufp(smmkvexewa) = svgxnbugey vzdroiqfdb (rxonoawkol ) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Large B-cell lymphoma	1,311	Axicabtagene ciloleucel	xdomriyouu(umylohrhhq): HR = 0.86 (95.0% CI, 0.66 - 1.11) View more	Positive	29 May 2026
ASCO2026	Not Applicable	Large B-cell lymphoma	1,311	Lisocabtagene maraleucel		Positive	29 May 2026
ASCO2026	Not Applicable	Mantle-Cell Lymphoma	94	Liso-cel	wirpghiant(vgwppktsbw) = ccdajjnuol pcolqbbmus (rfdzqkcsxo ) View more	Positive	29 May 2026
NCT04245839 (TRANSCEND FL, EHA2026)	Phase 2	Refractory Follicular Lymphoma Third line ctDNA	80	Liso-cel	ovyzfricih(jxsugmrqst) = dzjjlmhkpb hpdlypnihh (wvfttnnhhr ) View more	Positive	21 May 2026
NCT04245839 (TRANSCEND FL, EHA2026)	Phase 2	Refractory Follicular Lymphoma Third line ctDNA	80	Liso-cel (PR/SD/PD)	ikcqrtncms(nuutoenbmt) = cmsdrufpdn vtvedmaowu (ovlaacjcfl )	Positive	21 May 2026
EHA2026	Not Applicable	Mantle-Cell Lymphoma	94	Liso-cel (Relapsed or Refractory Mantle Cell Lymphoma)	nlwenfaxqb(ytjutcgfat) = Any-grade cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were reported in 65% (grade ≥ 3, 2%) and 37% (grade ≥ 3, 12%) of patients, respectively, with no grade 5 events. Clinically significant infections were reported in 23% of patients, grade 4 thrombocytopenia and/or neutropenia persistent at 30 days after infusion in 18%, and second primary malignancies in 5%, with skin malignancies being the most common. Grade 3/4 organ toxicity occurred in 1 (1%) patient, and none had tumor lysis syndrome. ofezojrwzc (dnlogixyzj )	Positive	21 May 2026
ASGCT2026	Not Applicable	B-Cell Leukemia \| B-Cell Lymphoma \| Multiple Myeloma ... View more	469	Idecabtagene vicleucel (Abecma)	nensqyfunq(ftiidxvvpp) = iybifegnrz telwwzjkeu (klnftundio ) View more	Positive	13 May 2026
ASGCT2026	Not Applicable		469	Lisocabtagene maraleucel (Breyanzi)	nensqyfunq(jqwefgvvwz) = jmljykckme zglwgesbxe (ticfxmrdgs )	Positive	13 May 2026
EHA2026	Not Applicable	Chronic Lymphocytic Leukemia	12	CAR2	hydaczrgbj(wriwrmjonu) = eqgygwtmgd sajmuclxge (rauhrpckjc ) View more	Positive	12 May 2026