Actively Recruiting
Phase 1 Study of FIT-CD19-CAR-T Cell Therapy Infusion with Chemotherapy in Adults with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
Led by TriArm Therapeutics (Taiwan) Limited · Updated on 2025-07-23
12
Participants Needed
1
Research Sites
678 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of FIT-CD19-CAR-T ARM011 cells in adults with relapsed or refractory B-cell acute lymphoblastic leukemia ALL. This Phase 1, open-label study also looks at the anti-tumor activity, cell behavior, immune response, and exploratory biomarkers of the investigational treatment. ARM011 is given after a standard lymphodepleting chemotherapy regimen to prepare the body for the infusion. Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by an intravenous infusion of ARM011, an autologous CAR T-cell product made using a rapid manufacturing process. This dose-finding study uses a 33 design to determine safety and appropriate dosing. The treatment period includes monitoring for up to 24 months after the ARM011 infusion. Throughout the study, participants will be closely monitored for adverse events, cellular kinetics, persistence of ARM011 cells, immune responses, and preliminary anti-tumor effects. Assessments include clinical evaluations and laboratory tests over a follow-up period of up to two years. The study aims to evaluate both safety and feasibility of this investigational treatment.
CONDITIONS
Brief Title
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Research Team
R
Reta Ruan
Y
Yiming Gong, MD
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