A bispecific chimeric antigen receptor (CAR) T-cell therapy has shown “robust” activity in patients with relapsed/refractory non-Hodgkin lymphoma, according to a presentation at the AACR Annual Meeting 2023.
The CD19/CD20-directed CAR T-cell therapy produced a 91% overall response rate and a 73% complete response rate in this phase 1 trial.
The trial (ClinicalTrials.gov Identifier: NCT04007029) enrolled patients with diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL) after 2 or more lines of therapy and patients with mantle cell lymphoma (MCL), follicular lymphoma (FL), or chronic lymphocytic leukemia/small lymphocytic lymphoma after 3 or more lines of therapy.
A total of 11 patients were treated and evaluable — 5 with DLBCL, 4 with FL, 1 with PMBCL, and 1 with MCL. The patients’ median age at baseline was 58 years, and they had received a median of 3 prior lines of therapy.
Patients received CD19/CD20 CAR T-cell therapy after conditioning with fludarabine and cyclophosphamide. Eight patients received a cell dose of 50 x 106, and 3 received 200 x 106.
When results from both dose levels were combined, the overall response rate was 91%, and the complete response rate was 73%. Patients who received the higher dose had a complete response rate of 100%, and those who received the lower dose had a complete response rate of 63%.
At a median follow-up of 20.7 months, the median progression-free survival was 18.2 months. The median overall survival was not reached.
The most common adverse events (AEs) were anemia (100%), neutropenia (90%), and thrombocytopenia (90%). One grade 5 AE (hypocellular marrow) was reported. There were no cases of neurotoxicity.
Six patients (60%) had grade 1 cytokine release syndrome (CRS). There were no cases of CRS above grade 1. The median time to CRS onset was 8 days, and the median duration of CRS was 2.5 days. One patient received tocilizumab. None received corticosteroids.
“Our bispecific CART19/20 cells have shown robust activity and overall safety in patients with relapsed/refractory non-Hodgkin lymphoma,” said study presenter Benjamin R. Puliafito, MD, of the University of California, Los Angeles.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Puliafito BR, Walthers C, Ji B, et al. Phase 1 trial of CD19/CD20 bispecific chimeric antigen receptor-engineered naïve/memory T cells for relapsed or refractory non-Hodgkin lymphoma. AACR 2023. April 14-19, 2023. Abstract CT023.
This article originally appeared on Cancer Therapy Advisor