Phase 1 Study of SENL101 CAR-T Therapy for Adults With Relapsed or Refractory T-LBL or T-ALL

What this Trial Is About

Researchers are evaluating the tolerability and safety of SENL101, a CAR-T immunotherapy targeting CD7, in adults with relapsed or refractory T-lymphoblastic lymphoma T-LBL or T-cell acute lymphoblastic leukemia T-ALL. This Phase 1 open-label study also aims to preliminarily assess the efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and recovery of T and NK cells following treatment. The study involves a dose-escalation design where participants receive SENL101 autologous T cell injections. The treatment targets CD7-positive tumor cells detected by bone marrow flow cytometry or immunohistochemistry of extramedullary lesions. Participants must meet specific health and organ function criteria before receiving the infusion. During the trial, researchers will monitor participants for safety by tracking the incidence and severity of adverse events for 28 days after infusion. Additional assessments include blood tests, organ function evaluations, and immunological monitoring to understand the therapys effects and recovery times. The study will continue to follow participants until August 2038, with ongoing evaluations as indicated by the protocol.

CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study