Johnson & Johnson and Atreus Therapeutics Announce Breakthrough Efficacy of CD19/CD20 Dual-Targeting CAR-T Therapy C-CAR039 in Relapsed/Refractory Large B-Cell Lymphoma

▎Armstrong

On June 13, 2025, Johnson & Johnson announced the presentation of C-CAR039, a CD19/CD20 CAR-T therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL), at the 2025 European Hematology Association Annual Meeting (EHA).Phase 1b Clinical Trial in the United StatesData. As of February 7, 2025, 48 patients with advanced LBCL were enrolled, 22 (46%) of whom had received two or more lines of therapy. CRS side effects occurred in 38 (79%) patients, including grade 1 in 52%, grade 2 in 23%, and grade 3 in 4%. ICANS side effects occurred in 7 (15%) patients, including grade 1 in 8% and grade 3 in 6%.For the 22 patients receiving the RP2D dose (75 million cells), there were no cases of CRS or ICANS of grade 3 or higher.

In terms of efficacy, 42 patients were evaluable for response, with an ORR of 90.5%, a CR rate of 76.2%, and a median time to response of one month.For the 22 patients receiving the RP2D dose (75 million cells), the ORR was 95% and the CR rate was 80%.

For the 10 patients who received first-line treatment, the ORR was 100%, and the CR rate was 80%. For patients who received second-line or higher treatment, the ORR was 92%, and the CR rate was 75%.

Currently, there remains a significant unmet clinical need for R/R DLBCL, with a long-term remission rate of only 40% for CD19 CAR-T therapy.C-CAR039 has demonstrated excellent therapeutic potential, offering a promising new treatment option for patients with R/R DLBCL.

Summary

C-CAR039, independently developed by Cellular Biomedicine Group, was licensed to Johnson & Johnson in May 2023 for global rights outside Greater China for both C-CAR039 and C-CAR066. Under the agreement, Johnson & Johnson will pay an upfront fee of $245 million, undisclosed milestone payments, and a certain percentage of sales royalties. In addition to hematologic tumors, clinical trials for Cellular Biomedicine Group's CAR-T therapies for solid tumors and autoimmune diseases are also advancing.