Study of APRIL CAR-T Cell Therapy to Treat BCMATACI Positive Relapsed or Refractory Multiple Myeloma in Adults Aged 18 to 75

What this Trial Is About

Researchers are evaluating APRIL CAR-T cell therapy for patients with BCMATACI positive relapsed or refractory multiple myeloma. This is an early phase 1, single-arm, open-label study designed to explore the safety and dose-related safety of this treatment. The study is conducted at a single center and plans to enroll 36 patients who have relapsed or refractory multiple myeloma expressing BCMA or TACI markers. Each participant receives APRIL CAR-T cells through a single intravenous infusion. The study focuses mainly on monitoring dose-limiting toxicities within 28 days after infusion. The trial continues for up to two years to observe any treatment-emergent adverse events and evaluate the therapys impact on overall response, survival, and quality of life. No placebo or comparison group is involved, and the dose levels are selected based on similar clinical trials. Participants are closely monitored with regular assessments including overall response rate at various months up to two years, overall and event-free survival, and quality of life measures such as physical activity and daily living scores. Anxiety and depression levels are also evaluated periodically. Safety is followed up for up to two years post-infusion, with detailed evaluations of liver function, heart function, infection status, and general health throughout the study period.

APRIL CAR-T Cell Therapy for Patients With BCMA/TACI Positive Relapsed and/or Refractory Multiple Myeloma