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A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Sponsor: TriArm Therapeutics (Taiwan) Limited
Summary
This is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Official title: A Phase 1 Study of Fast-In-Time Autologous Anti-CD19 Chimeric Antigen Receptor T Cells (FIT-CD19-CAR-T Cells) Infusion for Subjects With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2025-07-15
Completion Date
2041-04-01
Last Updated
2025-07-23
Healthy Volunteers
No
Conditions
Interventions
ARM011
ARM011 is an autologous, CD19 targeted CAR T-cell product developed on fast-in-time (FIT) platform-a non-viral, 2-day rapid manufacturing process
Fludarabine
Administered prior to infusion of ARM011
Cyclophosphamide
Administered prior to infusion of ARM011
Locations (1)
National Taiwan University Hospital
Taipei, Taiwan