Phase 1 Study of Off-the-Shelf 4SCAR19U T Cell Therapy for Relapsed or Refractory B Cell Cancers

What this Trial Is About

Researchers are evaluating a new type of CAR T cell therapy called 4SCAR19U T cells for treating patients with CD19-positive B cell malignancies. This phase I trial aims to assess the feasibility, safety, and effectiveness of this universal CAR T cell product in patients who have relapsed or refractory hematological cancers. The study also investigates how these cells function and persist in the body. The trial is sponsored by Shenzhen Geno-Immune Medical Institute and conducted at multiple centers. The 4SCAR19U T cells are genetically engineered and produced in large amounts, allowing them to be stored and used off-the-shelf without needing to be custom-made for each patient. This makes treatment quicker and potentially more accessible, especially for patients with rapidly progressing disease or weakened immune systems after chemotherapy or radiotherapy. Participants will receive infusions of these universal CD19-specific CAR T cells as the investigational therapy. Participants will be monitored for safety over 24 weeks following the infusion to observe any side effects or adverse events. The study will also evaluate the anti-tumor activity of the 4SCAR19U cells for up to one year. Assessments include clinical evaluations, laboratory tests, and tracking of the cells persistence in the body. The trial plans to enroll patients aged from 6 months to 75 years, with specific health and response criteria, and participation could last until the studys end date in 2030.

4SCAR19U T Cells Targeting B Cell Malignancies