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

Sponsor
TriArm Therapeutics (Taiwan) Limited
Study ID
NCT07066397
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARM011 — BIOLOGICAL
    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
  • Fludarabine — DRUG
    Administered prior to infusion of ARM011
  • Cyclophosphamide — DRUG
    Administered prior to infusion of ARM011

Study Details

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.

Key Dates

First listed
Jul 15, 2025
Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Apr 1, 2028
Completion
Apr 1, 2041

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ARM011 following lymphodepleting chemotherapy
    A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment with ARM011

Primary Outcome Measure

Incidence of adverse events [Safety and Tolerability] [ Time Frame: Up to 24 months after ARM011 infusion ]

Central Contacts

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