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) - P1 | "In a first-in-human study in China, C-CAR039, an autologous anti-CD19/CD20 bispecific CAR T-cell therapy, showed a CRR of 86% in pts with R/R LBCL and PFS and OS were not reached at 30mo median follow up (FU)... The safety, efficacy, and PK profile support selection of 75M CAR+ T-cells as the RP2D of JNJ-90014496 in R/R LBCL. CRR of 80% and no G3/4 ICANS/CRS from this first global study are promising, confirm previous findings in Chinese pts, and compare favorably to historical data with approved anti-CD19 CAR T-cell therapies. Longer FU is ongoing to confirm durability and further deepening of responses."

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

LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA TREATED WITH PRIZLONCABTAGENE AUTOLEUCEL (EHA 2025) - "Prizloncabtagene autoleucel (prizlon-cel), previously known as C-CAR039, is an autologous anti-CD20/CD19 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL)... With a median follow-up of 45.5 months, median PFS and OS was not reached. Prizlon-cel demonstrated a favorable safety profile, along with deep and durable responses in patients with r/r B-NHL, particularly in those with LBCL. The long-term follow-up results suggested the curative potential of prizlon-cel in this patient population."

Clinical • Clinical data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Primary Mediastinal Large B-Cell Lymphoma • Respiratory Diseases

A GLOBAL PHASE 1B STUDY OF JNJ-90014496, A CD19/CD20 BI-SPECIFIC CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPY, IN PATIENTS (PTS) WITH RELAPSED/REFRACTORY (R/R) LARGE B-CELL LYMPHOMA (LBCL) (EHA 2025) - "In a first-in-human study in China C-CAR039 an autologous anti-CD19/CD 0 bispecific CAR T-cell therapy demonstrated a CRR of 86% in pts with R/R LBCL and progression-free survival and overall survival were not reached at 30-mo median follow up... The safety efficacy and PK profile supports selection of 75M CAR+ T-cells as the RP D of JNJ-90014496 in pts with R/R LBCL. A CRR of 80% and no G3/4 ICANS (5% G1) or G3/4 CRS from this first global study are promising confirm previous findings in Chinese pts and compare favorably to historical data with approved anti-CD19 CAR T-cell therapies. Longer follow-up is ongoing to confirm durability and further deepening of responses."

Clinical • P1 data • Anemia • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Leukopenia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • CD20

AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025 (PRNewswire) - P=NA | N=NA | "Key Findings: The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients; Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively; With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached; KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively; KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively; No new safety signals were observed with longer follow-up."

Clinical data • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Mediastinal B Cell Lymphoma

Johnson & Johnson's dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma (PRNewswire) - P1b | N=230 | NCT05421663 | Sponsor: Janssen Research & Development, LLC | "These data were presented as an oral presentation at the 2025 European Hematology Association (EHA) Congress (Abstract #S239).....In the Phase 1b dose confirmation study (NCT05421663) in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an objective response rate (ORR) of 100 percent and a complete response rate (CRR) of 80 percent (95 percent confidence interval (CI), 69, 100). In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100)."

P1 data • Large B Cell Lymphoma

A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Active, not recruiting ➔ Completed

Trial completion • B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects (clinicaltrials.gov) - P1 | N=25 | Completed | Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine | Active, not recruiting ➔ Completed

Trial completion • B Cell Lymphoma • Hematological Malignancies • 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=10 | Completed | Sponsor: Peking Union Medical College Hospital | Trial completion date: Oct 2022 ➔ Jun 2024 | Recruiting ➔ Completed

Trial completion • Trial completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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