Phase III Study of CAR-T Cell Therapy for Adults with Relapsed or Refractory Malignant Hematologic Tumors

What this Trial Is About

Researchers are evaluating CAR-T cell therapy as a treatment for adults with relapsed or refractory malignant hematologic tumors, including various types of aggressive B-cell lymphoma, T-cell lymphoma, acute lymphoblastic leukemia, multiple myeloma, and myeloid tumors. This Phase III open-label study aims to investigate the safety, determine the maximum tolerated dose, and assess early effectiveness of CAR-T cell infusions in these conditions. The study uses a dose-escalation approach, starting with small groups of patients receiving increasing doses of CAR-T cells to find the safest maximum dose. After this, a larger group will receive the recommended dose to further evaluate how well the treatment works. The CAR-T cells used target specific tumor markers and are given as infusions. Different dose groups will receive between 1 million and 3 million CAR cells per kilogram of body weight, adjusted based on previous trial results. Participants will be monitored closely for adverse events within 28 days after treatment and followed for up to 24 months to assess response rates, duration of response, progression-free survival, and overall survival. The study involves regular visits with clinical evaluations, laboratory tests, and follow-up assessments to track safety and effectiveness. Participants will need to comply with study requirements, including visits, tests, and treatment procedures throughout the study duration.

The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors