Janssen Announces First-in-Human Ib Data for JNJ-90014496, a CD19/CD20 Bispecific CAR-T Therapy, Demonstrating 100% ORR in Relapsed/Refractory LBCL Patients

Jun 16, 2025 12:01 CST Updated 12:01

Johnson & Johnson

Medical Device R&D and Manufacturer

Source: PharmaCube Info

On June 13, Johnson & Johnson announcedJNJ-90014496（JNJ-4496）First Clinical Data from the Ongoing Phase Ib Study of JNJ-90014496, a Bispecific Anti-CD19/CD20 Dual-Targeted Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy, Being Investigated in Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL) Who Have Not Previously Received CAR-T Cell Therapy. The study results demonstrate the potential efficacy of JNJ-4496 in treating patients with R/R LBCL, including those with relapsed or refractory diffuse large B-cell lymphoma [R/R DLBCL]. R/R DLBCL is the most common and aggressive type of lymphoma originating from the lymphatic system, a form of blood cancer. These data were presented as an oral report at the 2025 European Hematology Association (EHA) Congress (Abstract).#S239）。

JNJ-4496（Previously known as C-CAR039, introduced fromCBMG Biotech), a bispecific CAR T targeting both CD19 and CD20 antigens, which are cell surface proteins commonly expressed on malignant B cells.This design (including the 4-1BB co-stimulatory domain) is intended to enhance binding affinity and persistence, and may also address common mechanisms of resistance in relapsed or refractory disease.。

In the Phase Ib dose-confirmation study (NCT05421663) for patients with R/R LBCL, patient data with a median follow-up of 4 months at the recommended Phase II dose (RP2D) were reported. The study established the RP2D of JNJ-4496 as 75 million CAR+ T cells. Among the 22 patients treated at the RP2D and evaluated for efficacy, prior treatments included...Patients receiving first-line treatment(n=10), the objective response rate (ORR) was 100%, and the complete response rate (CRR) was 80% (95% CI, 69, 100). Among those who had receivedPatients who have received 2 or more prior lines of therapyIn patients (n=12), the ORR was 92%, and the CRR was 75% (95% CI, 62, 100).

In the RP2D cohort of the study, no grade 3 or 4 cytokine release syndrome (CRS) cases were observed. Two patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS), with one case being grade 1 and the other grade 3. The grade 3 event occurred in a patient with central nervous system (CNS) lymphoma. Overall, 84% (n=21) of patients experienced grade 3/4 treatment-related adverse events (TEAEs), and 28% (n=7) reported serious TEAEs. The most common grade 3/4 TEAE was neutropenia (leukopenia, 72%). One patient had a grade 3 infection.

Krish Patel, MD, Chief Research Investigator and Director of Lymphoma Research at Sarah Cannon Research Institute (SCRI), stated:"Following the currently available single-antigen targeted CD19 CAR T-cell therapy, only about 40% of patients achieve long-term remission. The data presented today show encouraging clinical activity and promising safety, representing a step forward in providing a potential new treatment option for patients with the most common aggressive lymphoma."

These data have driven the development of Johnson & Johnson's CAR T therapy pipeline for B-cell malignancies and expanded the global collaboration and licensing agreement initiated in 2023 with AbelZeta (CBMG Biotech) to develop and commercialize next-generation CAR T cell therapies (excluding Greater China). A Phase I study on JNJ-4496 for the treatment of B-cell non-Hodgkin lymphoma (primarily LBCL) was conducted in China.

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