Early Phase 1 Study Evaluating In Vivo PICX CAR-T Cell Therapy for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effectiveness of an investigational in vivo CAR-T cell therapy called PICX Injection in adults with relapsed or refractory multiple myeloma. This early-phase, single-center, single-arm study focuses on patients whose disease has progressed despite prior treatments or who have high-risk features. The goal is to explore this novel therapy as a potential treatment option for this condition. Participants will receive a single intravenous infusion of PICX Injection and remain hospitalized for close monitoring during the month following treatment. Researchers will track adverse events and treatment responses carefully during this time. After discharge, participants will continue long-term follow-up visits for up to two years to assess disease status and how durable the response to treatment is over time. Throughout the study, participants will undergo regular evaluations including clinical exams, laboratory tests, and imaging to monitor safety and response. The main measures include determining the maximum tolerated dose and incidence of side effects within 28 days after infusion. Secondary outcomes will assess response rates, minimal residual disease negativity, progression-free survival, overall survival, and other efficacy indicators over the two-year follow-up. This thorough monitoring aims to gather important information on the therapys impact and safety profile.

In Vivo PICX CAR-T Therapy for R/R Multiple Myeloma