Phase 1 Study of Anti-CD7 CAR T-Cell Therapy for Patients Aged 6 to 65 With Relapsed or Refractory T-Lineage Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating anti-CD7 CAR T-cell therapy for patients with relapsed or refractory T-lineage acute lymphoblastic leukemia T-ALL. This phase I study aims to assess the safety and effectiveness of this novel therapy, which targets CD7, a marker present on T-ALL cells. The therapy uses anti-CD7 Protein Expression Blocker PEBL CAR T-cells to reduce the leukemia cell population and potentially achieve deeper remissions. Participants will receive the anti-CD7 PEBL CAR T-cell infusion in a single-arm treatment group. This approach helps prevent the T cells from attacking themselves while targeting the leukemia cells. The study includes a treatment period with infusion and follow-up assessments to monitor the persistence of CAR T-cells and disease response over time. Throughout the study, participants will undergo evaluations including flow cytometry to measure minimal residual disease MRD at one month post-infusion, echocardiograms to assess heart function, and other laboratory tests. Researchers will monitor safety, CAR T-cell presence in bone marrow, blood, and cerebrospinal fluid, and overall treatment response up to five years. The total study duration includes screening, treatment, and long-term follow-up.

CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia