prizloncabtagene autoleucel (JNJ-4496) / AbelZeta Pharma, Tongji University, J&J - LARVOL DELTA

A GLOBAL PHASE 1B STUDY OF JNJ–90014496, A CD19/CD20 BI–SPECIFIC CHIMERIC ANTIGEN RECEPTOR (CAR) T–CELL THERAPY, IN RELAPSED/REFRACTORY (R/R) LARGE B–CELL LYMPHOMA (LBCL) (ICML 2025) - No abstract available

Clinical • P1 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Prizloncabtagene autoleucel: a new CAR T cell for B-NHL. (PubMed, Blood) - No abstract available

Journal

A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. (PubMed, Blood) - P1 | "Patients with CD19 and/or CD20-positive r/r B-NHL received a 3-day lymphodepletion (cyclophosphamide: 300 mg/m2/d; fludarabine: 30 mg/m2/d) followed by an intravenous dose of prizlon-cel...Prizlon-cel showed 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. (ClinicalTrials.gov number: NCT04317885, NCT04655677, NCT04696432, NCT04693676)."

Journal • P1 data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=104 ➔ 230

Enrollment change • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

ELEVATION: A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma (clinicaltrials.gov) - P1/2 | N=112 | Recruiting | Sponsor: Shanghai AbelZeta Ltd. | Phase classification: P1b/2 ➔ P1/2 | N=72 ➔ 112 | Trial completion date: Mar 2027 ➔ Dec 2027 | Trial primary completion date: Mar 2027 ➔ Oct 2025

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD20

C-CAR039, A NOVEL ANTI-CD20/CD19 BI-SPECIFIC CAR T-CELL THERAPY SHOWS DEEP AND DURABLE CLINICAL BENEFITS IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA IN LONG TERM FOLLOW UP (EHA 2024) - "With median follow-up of 30. 0 months, C-CAR039 demonstrated a favorable safety profile with deep anddurable response in pts with r/r B-NHL, especially in LBCL pts."

CAR T-Cell Therapy • Clinical • Anemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Oct 2027 ➔ Oct 2028

CAR T-Cell Therapy • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

AbelZeta Announces Amendment to Worldwide Collaboration and License Agreement with Janssen to Include China (PRNewswire) - "AbelZeta Pharma, Inc...today announced an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company. Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL)....Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

C-CAR039, a Novel Anti-CD20/CD19 Bi-Specific CAR T-Cell Therapy Shows Deep and Durable Clinical Benefits in Patients with Relapsed or Refractory (r/r) B-Cell Non-Hodgkin Lymphoma (B-NHL) in Long Term Follow up (ASH 2023) - "At a longer median follow-up of 23.9 months, C-CAR039 demonstrated a favorable safety profile with deep and durable response in pts with r/r B-NHL, especially in LBCL pts."

CAR T-Cell Therapy • Clinical • Acute Myelogenous Leukemia • Anemia • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

AbelZeta Presents Data from Two Clinical Studies Relating to its Immuno-Oncology Drug Development at the 65th ASH Annual Meeting (PRNewswire) - N=48 | "AbelZeta Pharma, Inc...presented clinical data for both C-CAR039 for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL), and C-CAR066, for the treatment of patients with r/r large B-cell lymphoma (LBCL) who failed prior CD19 CAR-T therapy at the 65th American Society of Hematology (ASH) Annual Meeting...At a longer median follow-up of 30.0 months, C-CAR039 demonstrated a favorable safety profile with deep and durable response in patients with r/r B-NHL, especially in LBCL patients....Of the 43 LBCL patients, the ORR was 90.7%, with 86.0% CR. Median duration of response (DOR) was not reached. 23/47 (48.9%) patients remain in CR, 10 of them for more than 36 months. Median PFS has not been reached."

Clinical data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=104 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Apr 2027 ➔ Oct 2027

CAR T-Cell Therapy • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

AbelZeta Announces Two Abstracts Accepted for Presentation at the 65th ASH Annual Meeting (PRNewswire) - "AbelZeta Pharma, Inc...announced today that two abstracts relating to its immuno-oncology drug development have been accepted for presentation at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in San Diego, California, and online from December 9 to 12, 2023."

Clinical data • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=52 ➔ 92 | Trial completion date: Oct 2027 ➔ Apr 2027

CAR T-Cell Therapy • Enrollment change • Trial completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Janssen Research & Development, LLC | N=15 ➔ 52 | Trial completion date: Jul 2038 ➔ Oct 2027 | Trial primary completion date: May 2025 ➔ May 2026

CAR T-Cell Therapy • Enrollment change • Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

CAR-T: Janssen agrees with Cellular Biomedicine Group [Google translation] - "Janssen to pay $245 million upfront as part of an agreement with biotech Cellular Biomedicine Group (CBMG) to develop autologous CAR T-cell therapies targeting CD20 for the treatment of B-cell malignancies, the two announced. society. The agreement covers C-CAR066 and the bi-specific drug C-CAR039, which also targets CD19...Under the agreed terms, CBMG will grant Janssen a global license to develop and commercialize the CAR-T assets, with the exception of Greater China, where the companies will negotiate an option for Janssen to commercialize the products. In addition to the upfront payment, CBMG is entitled to additional future milestones and royalties on worldwide sales excluding Greater China."

Licensing / partnership • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects (clinicaltrials.gov) - P1 | N=25 | Active, not recruiting | Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2021 ➔ Dec 2023 | Trial primary completion date: Aug 2021 ➔ Jun 2023

Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Recruiting ➔ Active, not recruiting | N=10 ➔ 7 | Trial completion date: Oct 2022 ➔ Dec 2023 | Trial primary completion date: Jul 2022 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study of C-CARP039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=17 | Active, not recruiting | Sponsor: First Affiliated Hospital of Zhejiang University | Recruiting ➔ Active, not recruiting | N=10 ➔ 17 | Trial completion date: Oct 2022 ➔ Apr 2024 | Trial primary completion date: Jul 2022 ➔ Dec 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Cellular Biomedicine Group Announces Exclusive Collaboration and License Agreement with Janssen to Develop and Commercialize anti CD19 & CD20 Bi-Specific and anti CD20 CAR-Ts for Non-Hodgkin Lymphoma (PRNewswire) - "Cellular Biomedicine Group Inc...announced that the Company has entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen) for C-CAR039, an anti-CD19 & CD20 bi-specific chimeric antigen receptor T-cell (CAR-T) therapy, and C-CAR066, an anti-CD20 CAR-T, which have been studied for the treatment of Non-Hodgkin Lymphoma (NHL)....Under the terms of the agreement, Janssen will receive an exclusive license to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China, and the parties will negotiate an option for Janssen to develop the China territory subject to certain deadlines before the Company files the Biologics License Application (BLA) application in China. CBMG will transfer IND and studies for C-CAR039 (NCT05421663) and C-CAR066 (NCT05784441) to Janssen and will supply the initial clinical trial materials comprised of viral vector and plasmid, as well as assist Janssen on the technology transfer. "

Licensing / partnership • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Developing a Novel Anti-CD19/CD20 Bi-Specific Chimeric Antigen Receptor T (CAR-T) Cell Therapy for Relapsed/Refractory (r/r) B-Cell NHL (ASH 2020) - P1 | "Following apheresis to harvest T cells, C-CAR039 was manufactured and infused as a single intravenous dose after a standard 3-day cyclophosphamide/fludarabine conditioning regimen. C-CAR039 shows promising efficacy and a favorable safety profile in the early clinical trial in patients with r/r NHL. The early clinical efficacy signal is encouraging and compares favorably to anti-CD19 CAR-T therapies. These findings need to be evaluated in more patients with longer follow-up to confirm safety, efficacy and duration of response."

Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

[VIRTUAL] Safety and efficacy of a novel anti-CD20/CD19 bi-specific CAR T-cell therapy (C-CAR039) in relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL). (ASCO 2021) - P1 | "C-CAR039 was administered as a single intravenous dose after a 3-day cyclophosphamide plus fludarabine conditioning regimen . C-CAR039 demonstrated a favorable safety profile and promising efficacy in this early clinical trial in patients with r/r B-NHL that might allow it to differentiate from existing therapies . The early clinical efficacy signal is encouraging and compares favorably to anti-CD19 CAR-T and peer therapies . These findings will be evaluated in more patients with longer follow-up to confirm safety, efficacy and duration of response."

CAR T-Cell Therapy • Clinical • Anemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Inflammation • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD19 • CD20

A Study of C-CAR039 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: Cellular Biomedicine Group Ltd. | Not yet recruiting ➔ Recruiting

CAR T-Cell Therapy • Enrollment open • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD19

A Study of C-CAR039 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Cellular Biomedicine Group Ltd.

CAR T-Cell Therapy • New P1 trial • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6 • CD19

CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (PRNewswire) - "Cellular Biomedicine Group Inc...announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens, both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL)."

Fast track designation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

CBMG Receives FDA Clearance of IND Application for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (PRNewswire) - "Cellular Biomedicine Group Inc...today announced that the Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1b clinical development of its chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD20 (C-CAR039). C-CAR039 is a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens in the treatment of patients with relapsed or refractory non-Hodgkin lymphoma (r/r B-cell NHL)."

IND • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology