A Phase 2 clinical trial in China has demonstrated promising, durable responses to relmacabtagene autoleucel (relma-cel), an anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, for patients with relapsed or refractory mantle cell lymphoma (MCL). The study, involving 70 heavily pretreated patients, evaluated both the efficacy and safety of relma-cel, a treatment already approved in China for relapsed/refractory large B-cell lymphoma and follicular lymphoma.
The trial, conducted across multiple centers in China, focused on individuals whose MCL had returned after, or failed to respond to, previous treatments. Participants had a history of at least six months with the disease and had experienced continued activity despite stable standard treatment for at least two months prior to enrollment. Researchers assessed four different dose levels of relma-cel – 25 x 106, 50 x 106, 75 x 106, and 100 x 106 anti-CD19 CAR-T cells – following lymphodepletion chemotherapy with fludarabine and cyclophosphamide.
The primary objectives of the study were to identify dose-limiting toxicities (DLTs) and assess overall adverse events (AEs). Secondary endpoints included pharmacokinetic analysis, the rate of response as measured by the SLE Responder Index (SRI), and changes in disease activity scores using the SELENA-SLEDAI, BILAG-2004, and Physician’s Global Assessment (PGA) scales. The trial is registered on ClinicalTrials.gov under the identifier NCT05765006.
Relma-cel utilizes the same CAR construct as liso-cel, featuring a 4-1BB costimulatory domain. As a domestically approved CD19 CAR-T therapy in China, relma-cel represents a potential shift in the treatment paradigm for relapsed/refractory MCL, offering a new option for patients with limited alternatives. The National Medical Products Administration (NMPA) previously approved relma-cel, recognizing its long-term efficacy in relapsed/refractory large B cell lymphoma (LBCL).
Beyond lymphoma, a separate phase I open-label clinical trial is evaluating relma-cel’s impact on patients with moderately to severely active systemic lupus erythematosus (SLE), an autoimmune disease. This trial aims to determine if the CAR-T therapy can achieve durable B cell depletion and long-term remission in SLE patients, building on the success of CAR-T therapy in cancer treatment.
