NCT07066397

A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: TriArm Therapeutics (Taiwan) Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	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
DRUG	Fludarabine	Administered prior to infusion of ARM011
DRUG	Cyclophosphamide	Administered prior to infusion of ARM011

Timeline

• Start date: 2025-07-15
• Primary completion: 2028-04-01
• Completion: 2041-04-01
• First posted: 2025-07-15
• Last updated: 2025-07-23

Locations

1 site across 1 country: Taiwan