Delving into the Latest Updates on Prizloncabtagene autoleucel with Synapse

1)评价C-CAR039治疗复发或难治性大B细胞淋巴瘤（LBCL）受试者的长期安全性；2)评价C-CAR039治疗复发或难治性LBCL受试者的长期生存情况；3）评价C-CAR039细胞制剂长期的药代动力学；4）评价C-CAR039治疗复发或难治性LBCL受试者的长期免疫原性；5）评价C-CAR039治疗复发或难治性LBCL受试者的长期疗效（入组时处于缓解状态的受试者）。

[Translation]

1) Evaluate the long-term safety of C-CAR039 in the treatment of subjects with relapsed or refractory large B-cell lymphoma (LBCL); 2) Evaluate the long-term survival of subjects with relapsed or refractory LBCL treated with C-CAR039; 3) Evaluate the long-term pharmacokinetics of C-CAR039 cell preparations; 4) Evaluate the long-term immunogenicity of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL; 5) Evaluate the long-term efficacy of C-CAR039 in the treatment of subjects with relapsed or refractory LBCL (subjects in remission at the time of enrollment).

Start Date21 Jun 2023

Sponsor / Collaborator

Shanghai Cellular Biopharmaceutical Group Ltd.

NCT05800977

/ RecruitingPhase 1/2

A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma

This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).

Start Date22 Feb 2023

Sponsor / Collaborator

Shanghai AbelZeta Ltd.

NCT05421663

/ Active, not recruitingPhase 1/2

A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma

This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

Start Date12 Aug 2022

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Prizloncabtagene autoleucel

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100 Translational Medicine associated with Prizloncabtagene autoleucel

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100 Patents (Medical) associated with Prizloncabtagene autoleucel

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Literatures (Medical) associated with Prizloncabtagene autoleucel

03 Apr 2025·BLOOD

A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma

Article

Author: Yang, Min ; Yao, Yihong ; Zhang, Yan ; Yao, Xin ; Ye, Shiguang ; Lan, Liping ; Zhou, Lili ; Zhao, Jing ; Li, Lanfang ; Zheng, Chengxiao ; Zhu, Kevin ; Wan, Hui ; Li, Jing ; Liang, Aibin ; Zhu, Dan ; Yu, Wenjuan ; Zhang, Huilai ; Zhou, Daobin ; Li, Ping ; Huang, Jiaqi ; Jin, Jie

Abstract:

Prizloncabtagene autoleucel (prizlon-cel), a novel bispecific chimeric antigen receptor T cell, targets and eliminates CD19/CD20-positive tumor cells. This phase 1, open-label study investigated the safety and efficacy of prizlon-cel in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). Patients with CD19 and/or CD20-positive R/R B-NHL received a 3-day lymphodepletion (cyclophosphamide: 300 mg/m2 per day; fludarabine: 30 mg/m2 per day) followed by an IV dose of prizlon-cel. The primary end points were dose-limiting toxicity (DLT) and incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points included overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). Of the 48 patients infused prizlon-cel, 44 had large B-cell lymphoma (LBCL). No patient experienced DLT. Cytokine release syndrome occurred in 93.8% of the patients, with only 1 case of grade 3. Immune effector cell-associated neurotoxicity syndrome occurred in 6.3% of patients, with no grade 3 or higher events. The most common grade 3 or higher TEAEs were neutropenia (83.3%) and leukopenia (50%). The ORR and complete response (CR) rates in all patients were 91.5% and 85.1%, respectively, and in LBCL patients, ORR was 90.7% with 86.0% CR. With median follow-up of 30.0 months, median DOR, PFS, and OS were all not reached. Kaplan-Meier estimate of 2-year DOR, PFS, and OS rates were 66.0%, 62.6%, and 76.5%, respectively. Prizlon-cel had a favorable safety profile and a high and durable response in patients with R/R B-NHL, suggesting a promising treatment option for patients with R/R B-NHL. These trials were registered at www.clinicaltrials.gov as #NCT04317885, #NCT04655677, #NCT04696432, and #NCT04693676.

03 Apr 2025·BLOOD

Prizloncabtagene autoleucel: a new CAR T cell for B-NHL

Communications

Author: Sureda, Anna ; Mussetti, Alberto

37

News (Medical) associated with Prizloncabtagene autoleucel

17 Aug 2026

·allsci.com

J&J hands C-CAR039 back to AbelZeta amid pivot toward in vivo CAR-T

Johnson & Johnson's Janssen Biotech has returned global rights to Maryland-based AbelZeta Pharma's anti-CD19/CD20 bispecific CAR-T cell therapy prizloncabtagene autoleucel (C-CAR039), unwinding a 2023 licensing deal under which Janssen paid USD 245 million upfront for rights to C-CAR039 and a second CAR-T asset outside Greater China. AbelZeta has since received US FDA clearance of an investigational new drug (IND) application to advance C-CAR039 in US trials for relapsed or refractory (r/r) large B-cell lymphoma (LBCL). The July 2026 rights return restores to AbelZeta development, regulatory, manufacturing, commercialization, and out-licensing control of C-CAR039 globally. Financial terms were not disclosed. AbelZeta said it is working with the US FDA to finalize protocols for two US populations: third-line or later LBCL patients previously treated with CAR-T and second-line CAR-T-naive patients. The asset returns with a relatively mature clinical dataset. Long-term results presented at the European Society for Blood and Marrow Transplantation in March 2026 covered 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL). AbelZeta reported an overall response rate (ORR) of 91.5%, a complete response (CR) rate of 85.1%, and median progression-free survival of 60.1 months at a median follow-up of 53.9 months. A registrational Phase II study in CAR-T-naive r/r LBCL remains ongoing in China. Janssen previously revealed it was ending development of C-CAR-039 (also known as JNJ-4496) in May this year. C-CAR039 targets CD19 and CD20 simultaneously, an architecture intended to reduce antigen escape following CAR-T treatment. Loss or downregulation of target antigen is one resistance mechanism associated with single-target CD19 CAR-T therapies including axicabtagene ciloleucel and tisagenlecleucel. J&J's decision to hand the program back comes as the company makes a much larger commitment to next-generation in vivo CAR-T. Later in July, J&J agreed to USD 785 million in initial payments to Sail Biomedicines, including a USD 465 million equity investment, to develop in vivo CAR-T therapies for immune-mediated diseases. The agreement also includes up to USD 140 million in development-related contingent payments and gives J&J an option to acquire Sail for USD 2.58 billion. The transactions involve different indications and development strategies and J&J has not linked the two decisions. Taken together, however, they highlight a shift in where the company is deploying new cell therapy capital: away from at least one externally licensed ex vivo autologous CAR-T oncology program while making a substantial investment in technology designed to generate CAR-T cells directly inside the patient. For AbelZeta, the return provides full control of a clinical-stage asset just as it enters US development. The company has also attracted recent interest elsewhere in its CAR-T pipeline. In January 2026, AstraZeneca agreed to acquire AbelZeta's remaining China rights to GPC3-targeted C-CAR031, giving AstraZeneca sole global development and commercialization rights to the asset. In July, AbelZeta's CD20/BCMA bispecific C-CAR168 received EMA PRIME designation for lupus nephritis and systemic lupus erythematosus and US FDA clearance for a registrational Phase II trial in refractory lupus nephritis. One question remains over the second asset covered by the original Janssen relationship. A December 2023 amendment gave Janssen an option to obtain exclusive China commercialization rights to C-CAR039 and C-CAR066. AbelZeta's latest disclosure addresses the return of C-CAR039 but does not clarify the current status of C-CAR066 or the earlier China option. The return also comes amid a broader revaluation of cell therapy partnering. Large pharmaceutical companies have committed billions of dollars to in vivo CAR-T platforms during 2025–2026, reflecting interest in approaches that could eliminate the complex ex vivo manufacturing and treatment pathway required for conventional autologous CAR-T. For AbelZeta, the immediate question is whether the long-term Chinese clinical results for C-CAR039 can translate into competitive efficacy in US LBCL populations, including patients who have already failed a previous CAR-T therapy. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Cell TherapyPhase 2ImmunotherapyClinical ResultLicense out/in

17 Aug 2026

·www.biospace.com

J&J hands lymphoma bispecific CAR T back to AbelZeta

iStock, Yutthana Gaetgeaw Johnson & Johnson secured rights to prizlon-cel in 2023 for $245 million upfront. The asset in June last year showed a 100% response rate as a second-line option in a Phase 1b study for 10 patients with relapsed or refractory large B cell lymphoma. Johnson & Johnson has given up on an investigational CAR T therapy for large B cell lymphoma that the pharma had previously licensed from AbelZeta Pharma. Rights to the asset, dubbed prizloncabtagene autoleucel (prizlon-cel), were returned to AbelZeta in July, the U.S.- and China-based company said in a Sunday release . Prizlon-cel is being developed for the treatment of third- or later-line large B cell lymphoma (LBCL). J&J through its former Janssen subsidiary fronted $245 million in May 2023 to secure the exclusive right to develop and commercialize prizlon-cel—alongside other CAR T assets—outside the Greater China region. The pharma at the time also agreed to pay certain development, regulatory and sales milestones, though these remain undisclosed. A few months later, in December that year, the companies amended the agreement to give J&J the option to obtain the exclusive rights to prizlon-cel in China. The financial terms of this arrangement were likewise kept under wraps. BioSpace has reached out to J&J for more details regarding the decision to return prizlon-cel to AbelZeta and the status of the partnership. The asset no longer appears on J&J’s pipeline page .The pharma listed prizlon-cel—which it labeled JNJ-4496—in its full-year 2025 report in January, but the molecule no longer appeared in the company’s first quarter presentation in April. Cell therapy J&J’s Dual-Targeting CAR T Hits 80% Complete Response in Early Lymphoma Study Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta. June 16, 2025 · 2 min read · Tristan Manalac Read more In June last year, J&J released Phase 1b data showing that prizlon-cel elicited a treatment response in all dosed patients with relapsed or refractory LBCL who had undergone one prior line of therapy. Eight of the 10 patients showed a complete response. For the 12 patients receiving the candidate as a third-line treatment, overall response rate was 92% and complete response rate was 75%. Analysts from Truist Securities at the time called these outcomes “compelling,” representing what they said would be an “encouraging step up” from Gilead’s Yescarta, currently the standard of care in LBCL. Yescarta’s complete response rate is 65% in the second-line setting, according to its label . The decision to divest prizlon-cel comes as J&J buffs up other areas of its CAR T portfolio. Late last month, the pharma paid $785 million upfront—and earmarked up to $140 million—to partner with Sail Biomedicines to advance in vivo CAR T therapies for immune indications. The agreement also gives J&J the option to outright acquire Sail in the future for $2.58 billion. CAR-T J&J secures right to take the helm in up to $925M Sail CAR T pact As part of the collaboration, Johnson & Johnson will have an exclusive option to acquire Sail Biomedicines for an additional $2.58 billion. July 30, 2026 · 2 min read · Tristan Manalac Read more

Phase 1Clinical ResultCell TherapyAcquisitionImmunotherapy

17 Aug 2026

·www.prnewswire.com

AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma

ROCKVILLE, Md. and SHANGHAI, Aug. 16, 2026 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL). In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve. The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company's early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months. "We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy." The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against hematological malignancies, inflammatory and immunological diseases and solid tumors. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies. Forward-Looking Statements Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.'s ("AbelZeta" or the "Company") control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. Company Contact: Sarah Kelly Director of Communications AbelZeta Pharma, Inc. +1 (240) 552 5870 [email protected] SOURCE AbelZeta Pharma, Inc. 21% more press release views with Request a Demo

Phase 2ImmunotherapyCell TherapyINDDrug Approval

100 Deals associated with Prizloncabtagene autoleucel

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mediastinal large B-cell lymphoma	Phase 2	China	Shanghai AbelZeta Ltd.	22 Feb 2023
Diffuse Large B-Cell Lymphoma	Phase 2	United States	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	Australia	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	Canada	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	Denmark	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	Netherlands	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	South Korea	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	Spain	Janssen Research & Development LLC	12 Aug 2022
Diffuse Large B-Cell Lymphoma	Phase 2	United Kingdom	Janssen Research & Development LLC	12 Aug 2022
Non-Hodgkin Lymphoma	Phase 1	United States	AbelZeta Pharma, Inc.	14 Dec 2021

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05421663 (EBMT2026)	Phase 1	Large B-cell lymphoma CD20 \| CD19	51	PRIZLO-CEL 2.0 million (M) CAR-T cells/kg	wlrwpacnhs(kdffyowgyf) = erywcivjmw smcvywfgel (hdvzeovqox ) View more	Positive	22 Mar 2026
				PRIZLO-CEL 150M CAR-T cells	nsnzhtunbt(uremblchju) = xyfjzoggtb imaalelixx (udfzofwcsh ) View more
NCT05421663 (ASH2025)	Phase 1	Large B-cell lymphoma CD20 \| CD19	51	JNJ-90014496 (both CD20 and CD19 high/medium)	bigczrfsyh(mzstfwiynb) = tqwqnqtlww swvtyuffjx (lwockpkrmn ) View more	Positive	06 Dec 2025
				JNJ-90014496 (at least 1 antigen low)	bigczrfsyh(mzstfwiynb) = emehloqohz swvtyuffjx (lwockpkrmn ) View more
NCT05421663 (PipelineReview) Manual	Phase 2	Large B-cell lymphoma	22	JNJ-4496 RP 2D (received one prior line of therapy)	envoghrwet(wgqlddpmcy) = hxboorbkeb xbrcodurno (onogzolmdt ) View more	Positive	14 Jun 2025
				JNJ-4496 RP 2D (received two or more prior lines of therapy)	envoghrwet(wgqlddpmcy) = fmmfjrmrtk xbrcodurno (onogzolmdt ) View more
EHA2025 Manual	Not Applicable	B-cell lymphoma refractory \| B-cell lymphoma recurrent	48	Prizloncabtagene autoleucel	vusbimuwjk(sbanegejce) = nouvwdpucw ldnsgnccth (zlgbjesxzi, 79.6 - 97.6) View more	Positive	14 May 2025
				Prizloncabtagene autoleucel (LBCL)	vusbimuwjk(sbanegejce) = wlocxaaicc ldnsgnccth (zlgbjesxzi ) View more
NCT05421663 (EHA2025) Manual	Phase 1	Large B-cell lymphoma \| Diffuse large B-cell lymphoma recurrent	48	JNJ-90014496 (all dose)	ulydudlmcp(srxuwpoyux) = rmryktwilg xtmvpsifjc (jybuktgguv ) View more	Positive	14 May 2025
				JNJ-90014496 75 million CAR+ T-cells	ulydudlmcp(qtbvcjdayr) = sdftkjwevk dcegtflhho (kspoqlcjze ) View more
NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (Pubmed) Manual	Phase 1	Non-Hodgkin Lymphoma CD20 Positive \| CD19 Positive	48	Prizloncabtagene autoleucel	kdujtscliq(otyziqhjsy) = mxnxgpiqxq hlcdylomaw (huetfnvqsf ) View more	Positive	15 Jan 2025
				Prizloncabtagene autoleucel (Large B-cell lymphoma (LBCL))	jqtljyewyh(acvgnzxyaa) = suxyuatcnz owqbrmwiwg (pknyphcxeg ) View more
NCT04693676 \| NCT04655677 \| NCT04317885 \| NCT04696432 (C-CAR039, EHA2024)	Phase 1	B-cell lymphoma refractory CD20 \| CD19	48	C-CAR039	nsfwjfkidk(xzrrofnswe) = tydapebjec jfxnivtmbr (qqfatqpqxz ) View more	Positive	14 May 2024
CTR20250125 (ASH2023) Manual	Not Applicable	B-Cell Lymphoma	48	C-CAR039	rtityqixki(hqequjclek) = juyvdgmzbw whgqwfooaw (hbmsqoqxqo ) View more	Positive	11 Dec 2023
NCT04317885 (ASCO2021)	Phase 1	B-cell lymphoma refractory	28	C-CAR039	izkpscycrk(jmyuvqerzd) = fsqrrthisd yjtwqogcfu (plpspqnfjh ) View more	-	28 May 2021