clinical trial · NCT07066397
A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
TriArm Therapeutics (Taiwan) Limited·phase1·recruiting·n = 12
Acute Lymphoblastic LeukemiaARM011FludarabineCyclophosphamide
brief 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.
started
Jul 15, 2025
primary completion
Apr 1, 2028
completion
Apr 1, 2041
last updated
Jul 23, 2025
detailed description
This is an open-label, single arm, Phase 1 study to evaluate the safety and tolerability of FIT-CD19-CAR-T (ARM011) administered intravenously (IV) following a standard lymphodepleting (LD) chemotherapy regimen of cyclophosphamide and fludarabine in subjects with relapsed/refractory acute lymphoblastic leukemia (ALL). This dose finding study will use a 3+3 design.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol