Krish Patel, MD, Medical Oncologist at Sarah Cannon Research Institute, discusses first results from a study evaluating CAR-T cell therapy for large B cell lymphoma (LBCL).
LBCL is a form of non-Hodgkin lymphoma. Lymphomas occur when cells of the immune system, B lymphocytes, grow and multiply uncontrollably. It can start in the lymph nodes or outside of the lymphatic system in the gastrointestinal tract, testes, thyroid, skin, breast, bone, or brain. Often, the first sign of is a painless rapid swelling in the neck, armpit, abdomen, or groin caused by enlarged lymph nodes. Other symptoms include night sweats, unexplained fevers, and weight loss.
Clinical Trial Results
First results from a global phase 1b study (NCT05421663) evaluating JNJ-90014496, a CD19/CD20 bispecific CAR-T cell therapy, in adult patients with relapsed/refractory LBCL was recently presented at the European Hematology Association 2025 meeting. Primary endpoints of the study are recommended phase 2 dose and safety. Secondary endpoints include objective response rate (ORR), complete response rate (CRR), time to first response, and pharmacokinetics.
As of February 2025, 48 patients with CAR-T naïve, heavily pretreated R/R LBCL were treated with JNJ-90014496. At a median follow-up of six months across all doses, 79% of patients cytokine release syndrome with median time to onset of three days and median duration of eight days. In 42 evaluable patients across all doses, ORR was 90.5% and CRR was 76.2%. Median time to first response was one month.
Grade 3/4 treatment emergent adverse events (TEAEs) were observed in 83% and 25% of patients, respectively. The most common grade 3/4 TEAEs were neutropenia, leukopenia, anemia, and thrombocytopenia.
The identified recommended phase 2 dose was 75M CAR+ T-cells. At this dose, in 20 evaluable patients with a median follow-up of three months, ORR was 95% and CRR was 80%.
At the identified recommended phase 2 dose, there were no grade 3/4 cytokine release syndrome, however 86% of patients had grade 1/2 cytokine release syndrome. Additionally, there were no grade 3/4 ICANS and only 5% of patients had grade 1 ICANS. At this dose, 77% had grade 3/4 TEAEs and 23% had serious TEAEs. The most common grade 3/4 TEAEs were neutropenia and lymphopenia.
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To learn more about LBCL and other rare cancers, visit https://checkrare.com/diseases/cancers/
