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RECRUITING
NCT07066397
PHASE1

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

Sponsor: TriArm Therapeutics (Taiwan) Limited

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan