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

NCT07066397 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-07-23

No results posted yet for this 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.

Conditions

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

Sponsors & Collaborators

  • TriArm Therapeutics (Taiwan) Limited

    lead INDUSTRY

Principal Investigators

  • Hosein Kouros-Mehr, MD, PhD · TriArm Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2028-04-01
Completion
2041-04-01

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066397 on ClinicalTrials.gov