Johnson & Johnson is providing a first look at clinical data for its dual-targeting blood cancer CAR-T program.
In a phase 1b trial of patients with relapsed or refractory large B-cell lymphoma, 22 patients who received the recommended phase 2 dose of the CAR-T were included in the efficacy data with a median follow-up of 4 months. Of the 10 patients who had received one line of prior treatment, an objective response rate (ORR) of 100% was recorded, with all signs of cancer were undetectable for eight of the patients, J&J announced in a June 13 release.
For 12 patients who had received two or more previous therapies, the ORR was 92% and the complete response rate was 75%, the New Jersey company said.
In the trial’s 25-patient safety arm, 84% had grade 3 or 4 treatment-related adverse events, with 28% of patients experiencing serious side effects.
Within the cohort, there were no cases of grade 3 or 4 cytokine release syndrome, the healthcare giant said. One patient experienced grade 1 immune effector cell-associated neurotoxicity syndrome (ICANS), while another patient with central nervous system lymphoma experienced grade 3 ICANS.
The phase 1b trial’s primary endpoints are the occurrence of adverse events, including dose-limiting toxicities, and the determination of the recommended phase 2 dose, which J&J said in the release was 75 million CAR T-cells. J&J did not mention dose-limiting toxicities in the release.
J&J presented the data at the 2025 European Hematology Association conference in Milan, Italy. A global, open-label component of the phase 1b study is still ongoing.
The autologous CAR-T targets both CD19 and CD20, cell surface proteins commonly expressed by cancerous B cells.
“Only about 40% of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies," Krish Patel, M.D., the director of lymphoma research at Nashville-based Sarah Cannon Research Institute and principal investigator of the study, said in the release. "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 came to J&J through a 2023 collaboration and licensing agreement with Chinese-American biotech AbelZeta (formerly Cellular Biomedicine Group). Through that deal, J&J’s pharma unit Janssen paid $245 million upfront for the ex-China rights to JNJ-4496 (called C-CAR039 in China) and another CD20-targeting CAR T called C-CAR066.
The AbelZeta deal marked J&J’s return to the CAR-T field after the 2022 approval of Legend Biotech-partnered Carvykti. While the pharma’s competitors, like Novartis, Gilead and AstraZeneca were pushing forward in the area at the time, J&J chose to hang back until the right opportunity came along.
The cell therapy field has since been thinning out amid high costs and clinical struggles. Cell therapy biotechs like Carisma Therapeutics and Vor Bio announced they were shutting down earlier this year, while CAR-T company Cargo Therapeutics dumped all of its assets and laid off 90% of its staff in March.