Tests a CAR-T cell therapy in adults with relapsed or hard-to-treat leukemia
Tests a patient's own CD19-targeted immune cells in adults with relapsed B-cell leukemia.
Plain-language title generated from the registry record
Registry title: A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
Key facts
- Where
- Taipei, TaiwanSee the site
- Phase
- Phase 1
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TriArm Therapeutics (Taiwan) Limited
- Trial code
- NCT07066397
- Record updated
- 23 July 2025
- Original description
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.Read full original descriptionShow less
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 is a Phase 1 study to evaluate FIT-CD19-CAR-T (ARM011) safety and tolerability, anti-tumor activity, cellular kinetics, immunogenicity, and exploratory biomarkers.
Inclusion: Male or female subjects age ≥18 years; Diagnosis of ALL; Refractory to or relapsed after current standard treatment, and not suitable or unable to wait for other treatment options; Disease burden: Bone marrow with evidence of disease; Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2; Adequate organ functions; Life expectancy ≥12 weeks.
Exclusion: Prior anti-CD19 therapy (other than blinatumomab); Subjects who have experienced Grade 3 or higher cytokine release syndrome (CRS)/neurotoxicity following blinatumomab; autoimmune disease resulting in end-organ injury or requiring systemic immunosuppression within the last 2 years; History or presence of cardiac or CNS disorders as defined in the protocol; Active central nervous system (CNS) involvement of ALL; Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis.