Phase 12 Study of Biomarker-Guided Dual-Target CAR-T Cell Therapy for Adults With Relapsed or Refractory Blood Cancers

What this Trial Is About

Researchers are evaluating dual-target CAR-T cell therapies in adults with relapsed or refractory blood cancers. This Phase 12 umbrella study assigns participants to different CAR-T modules based on the presence of specific antigen combinations on their malignant cells to reduce the chance of the cancer escaping treatment. The study aims to determine the safety, recommended dose, and initial antitumor activity of each dual-target module while matching treatment to disease biology. Participants undergo screening including bone marrow and blood tests to identify the best CAR-T module from options like CD19CD22, CD19CD20, BCMACD19, and others. Treatment includes leukapheresis to collect cells, optional bridging therapy, lymphodepletion with fludarabine and cyclophosphamide, followed by infusion of the selected dual-target CAR-T cells. Different modules may be given as tandem or sequential infusions depending on safety and manufacturing needs. During the study, participants are closely monitored for safety through the first 28 days, then followed for efficacy up to 24 months. Assessments include response rates, minimal residual disease negativity, duration of response, and survival. Long-term safety follow-up of gene-modified cells may continue up to 15 years. Participants must comply with study visits and procedures including blood tests, imaging, and clinical evaluations throughout this period.

Adaptive Dual-Target CAR-T Cells for Relapsed or Refractory Hematologic Malignancies