FIT-CD19 CAR-T (ARM011) therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
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
This will test whether a non-viral CD19 CAR-T therapy (ARM011), given after short lymphodepleting chemotherapy, is safe and helps adults with relapsed or refractory B-cell acute lymphoblastic leukemia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | TriArm Therapeutics (Taiwan) Limited Industry-sponsored |
| Drugs / interventions | blinatumomab, CAR-T, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07066397 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with relapsed or refractory acute lymphoblastic leukemia, measurable bone marrow disease, ECOG ≤2, adequate organ function, and life expectancy of at least 12 weeks who cannot wait for or are unsuitable for other treatments are ideal candidates.
Not a fit: Patients with active CNS involvement, prior anti-CD19 therapy (except blinatumomab), prior severe CRS/neurotoxicity from blinatumomab, recent systemic immunosuppression for autoimmune disease, or certain cardiac/CNS disorders are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, this approach could offer an effective CAR-T option produced with a non-viral, faster manufacturing method that may shorten time to treatment for patients with relapsed/refractory ALL.
How similar studies have performed: Licensed CD19 CAR-T therapies have produced high remission rates in relapsed/refractory B-ALL, but non-viral fast CAR approaches like FIT-CD19 are newer and have less clinical experience to date.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Reta Ruan
- Email: reta@triarm.com
- Phone: +86 13641883361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.