Study of QI-019A CAR-T Gene Therapy for Safety and Early Effectiveness in Adults With Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are studying QI-019A, a gene therapy using a lentiviral vector to create CAR-T cells inside the body, for patients with relapsed or refractory multiple myeloma MM. This early-phase clinical trial focuses on assessing the safety, tolerability, and preliminary effectiveness of this treatment in patients who have undergone at least two prior anti-MM therapies but still have progressing disease. Participants will receive QI-019A as a single-arm, open-label treatment where the drug is administered in vivo to modify T cells directly within the patient. The study uses a dose-escalation design to determine safe dosing. The therapy aims to target BCMACD19 markers on cancer cells. The trial includes detailed monitoring for side effects and treatment response over time. During the study, participants undergo regular assessments including blood tests, imaging, and clinical evaluations to monitor safety and measure treatment effects such as response rate and survival. Researchers track adverse events and pharmacokinetic markers for up to 28 days post-infusion and continue to follow patients for up to two years to evaluate longer-term outcomes. Overall participation spans from treatment through extended follow-up to observe lasting effects and safety.

A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019A in Patients With Relapsed/Refractory Multiple Myeloma.