FIT-CD19 CAR-T (ARM011) therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, single-arm Phase 1, dose-finding study using a 3+3 escalation design to determine safe dosing of FIT-CD19-CAR-T (ARM011). Participants receive standard lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by an intravenous infusion of ARM011. Key outcomes include safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarker analyses. The protocol enrolls adults with relapsed or refractory ALL and requires measurable bone marrow disease at entry.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Male or female subjects age ≥18 years
2. Diagnosis of ALL
3. Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options
4. Disease burden: Bone marrow with evidence of disease.
5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
6. Adequate organ functions
7. Life expectancy ≥12 weeks

Key Exclusion Criteria:

1. Active central nervous system (CNS) involvement of ALL
2. Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
3. Prior anti-CD19 therapy (other than blinatumomab)
4. Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab.
5. autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years.
6. History or presence of cardiac or CNS disorders as defined in the protocol

Where it's running

• National Taiwan University Hospital
  Taipei, Taiwan Recruiting

Study contacts

• Study coordinator: Reta Ruan
• Email: reta@triarm.com
• Phone: +86 13641883361

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.