prizloncabtagene autoleucel (C-CAR039) / AbelZeta Pharma, Tongji University - LARVOL DELTA

Prizloncabtagene Autoleucel (Prizlon-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma Post FDA Approved CAR T-cell Therapy (clinicaltrials.gov) - P2 | N=55 | Not yet recruiting | Sponsor: AbelZeta Inc.

New P2 trial • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • BCL2 • MYC

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 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

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

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=166 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Trial primary completion date: Dec 2028 ➔ Jul 2041

Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

AbelZeta Pharma…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)…for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL) (PRNewswire) - "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."

IND • Licensing / partnership • Large B Cell Lymphoma

A Global Phase 1B Study of JNJ-90014496, A CD19/CD20 Bispecific Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL) (SOHO 2025) - P1/2 | "Context: In a first-in-human study in China, C-CAR039, an autologous anti-CD19/CD20 bispecific CAR T-cell therapy, demonstrated a complete response rate (CRR) of 86% in R/R LBCL pts; progression-free survival and overall survival were not reached at 30-month median follow-up (mFU)... The safety, efficacy, and pharmacokinetics profile supports selection of 75M CAR+ T cells as the RP2D of JNJ-90014496 in pts with R/R LBCL. A CRR of 80% and no G3/4 ICANS or G3/4 CRS from this first global study are promising."

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

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=166 | Active, not recruiting | Sponsor: Janssen Research & Development, LLC | Recruiting ➔ Active, not recruiting | N=439 ➔ 166

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

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=439 | Recruiting | Sponsor: Janssen Research & Development, LLC | Trial completion date: Mar 2029 ➔ Jul 2041

Trial completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Johnson & Johnson statement on investigational programs in large B-cell lymphoma (J&J Press Release) - "The investigational CD20 mono CAR-T cell therapy and CD19-CD20 bi-CAR-T programs will be discontinued. This is a strategic business decision based on the Company’s portfolio priorities and an assessment of the evolving large B-cell lymphoma treatment landscape. Patients currently enrolled in these ongoing clinical trials will continue to be supported, per study protocols."

Discontinued • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Mediastinal B Cell Lymphoma

LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA TREATED WITH PRIZLONCABTAGENE AUTOLEUCEL (EBMT 2026) - P1 | "Prizloncabtagene autoleucel, previously known as C-CAR039, is an autologous anti-CD20/CD19 dual-antigen targeting CAR-T therapy for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL)... With more than 4 years of follow-up, median PFS reached 60.1 months and median OS was not reached. Among LBCL patients, 20 patients (46.5%) maintained response without treatment and 28 patients (65.1%) remained alive. Together, these data demonstrated excellent durable efficacy and manageable safety profiles."

Clinical • Clinical data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

LONG-TERM CLINICAL OUTCOMES IN PATIENTS WITH RELAPSED OR REFRACTORY B-CELL NON-HODGKIN LYMPHOMA TREATED WITH PRIZLONCABTAGENE AUTOLEUCEL (EBMT 2026) - P1 | "Prizloncabtagene autoleucel, previously known as C-CAR039, is an autologous anti-CD20/CD19 dual-antigen targeting CAR-T therapy for the treatment of patients with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (B-NHL)... With more than 4 years of follow-up, median PFS reached 60.1 months and median OS was not reached. Among LBCL patients, 20 patients (46.5%) maintained response without treatment and 28 patients (65.1%) remained alive. Together, these data demonstrated excellent durable efficacy and manageable safety profiles."

Clinical • Clinical data • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

Biomarker Correlates of Clinical Outcomes from a Global phase 1b Study of JNJ-90014496, CD20/CD19 Bispecific Chimeric Antigen Receptor-T cell Therapy for Patients with Large B-cell Lymphoma (TCT-ASTCT-CIBMTR 2026) - P1/2 | "3. Interpret the relationships between CAR T-cell kinetics, cytokine profiles, tumor antigen expression, and clinical response outcomes, and discuss how these findings support continued development of JNJ- 4496 in LBCL."

Biomarker • CAR T-Cell Therapy • Clinical • Clinical data • P1 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD19 • CD20 • CD4 • CD8

A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=3 | Completed | Sponsor: Peking University | Recruiting ➔ Completed | N=18 ➔ 3

Enrollment change • Trial completion • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • BCL2 • BCL6

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. | Trial completion date: Dec 2027 ➔ Jun 2028 | Trial primary completion date: Oct 2025 ➔ Mar 2027

IO biomarker • Trial completion date • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • BCL2 • BCL6 • CD20

Biomarker correlates of clinical outcomes from a global Phase 1b study of JNJ-90014496, CD20/CD19 bi-specific chimeric antigen receptor (CAR) T-cell therapy for patients with large B-cell lymphoma (LBCL) (ASH 2025) - P1/2 | "Comparable CAR T-cell expansion and peripheral B-cell depletion were observed across alldoses. These findings, combined with lower cytokine levels at the 75M fixed dose, which may beindicative of an improved safety profile, support the selection of this dose as the RP2D of JNJ-4496 in ptswith R/R LBCL. High response rates were observed in pts with varying levels of CD19 or CD20, includingthose with low expression levels."

Biomarker • Clinical • Clinical data • P1 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • CD19 • CD20 • CD4 • CD8

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 • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Epstein-Barr Virus Infections • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • T Cell Non-Hodgkin Lymphoma • Thrombocytopenia

Best of Cell Therapy for Lymphoma: What We Learned in 2024 and 2025 (SOHO 2025) - P1/2, P2 | "Autologous CAR-T Therapy CD19 CAR-T New Regulatory Approvals In March 2024, the United States Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel (lisocel) for relapsed/refractory (R/R) chronic lymphocytic leukemia/ small lymphocytic lymphoma (CLL/SLL) after Bruton tyrosine kinase inhibitors (BTKis) and B-cell lymphoma 2 (BCL2) inhibitors, making it the first CAR-T approval in this disease...Long-Term Follow-up of Pivotal CD19 CAR-T Trials TRIAL (PRODUCT) LYMPHOMA SUBTYPE MEDIAN FU (MONTHS) ORR (%) CR (%) MEDIAN PFS (MONTHS) PFS (%) OS (%) NOTABLE SAFETY FINDINGS 64.6 90 75 (79% in FL cohort, 65% in MZL cohort) 62.2 53 (5 yr) 69 (5 yr) No new late signals ZUMA-5 (AXICEL) FL/MZL ( ≥ 3L) ELARA (TISA-CEL) FL ( ≥ 3L) 53 – * 69.1 53.3 50.2 (4 yr) 79.3 (4 yr) No new late signals; 6.2% secondary primary malignancies TRANSCEND FL (LISO-CEL) FL (2L+ high-risk/3L+) 29.5 – 30 95.7 – 97.1 94.2 – 95.7 NR 72.5 – 82.6 (2 yr) 88.2 –..."

IO biomarker • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hodgkin Lymphoma • Indolent Lymphoma • Large B Cell Lymphoma • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Oncology • Peripheral T-cell Lymphoma • Small Lymphocytic Lymphoma • T Cell Non-Hodgkin Lymphoma • CD22 • CD5 • IL15 • TNFRSF8

A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P1/2 | N=385 | Recruiting | Sponsor: Janssen Research & Development, LLC | Phase classification: P1 ➔ P1/2 | N=230 ➔ 385 | Trial primary completion date: May 2026 ➔ Dec 2028

Enrollment change • Phase classification • Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • 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

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