J&J shares encouraging early data for lymphoma CAR-T

Johnson & Johnson announced the first clinical data from an ongoing phase 1b study for its investigational dual-targeting anti-CD19/CD20 CAR-T cell therapy being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy.

In the phase 1b dose confirmation study, data at the recommended phase 2 dose (RP2D) were reported in patients with a median follow-up of four months. 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% and a complete response rate (CRR) of 80%. In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92% and the CRR was 75%.

“Only about 40 percent of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR-T therapies,” said Krish Patel, MD, Director of Lymphoma Research, Sarah Cannon Research Institute, and principal study investigator. “The data presented today show encouraging clinical activity and promising safety and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma.”

JNJ-4496 is a dual-targeting CAR-T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. The design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease.

These initial findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) — the most common type of aggressive lymphoma.

The results were shared as an oral presentation at the 2025 European Hematology Association Congress.