NCT07066397

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

Study 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.

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Interventions

ARM011BIOLOGICAL
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
FludarabineDRUG
Administered prior to infusion of ARM011
CyclophosphamideDRUG
Administered prior to infusion of ARM011

Study Locations

FacilityCityStateCountry
National Taiwan University HospitalTaipeiTaiwan

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026