A Phase 1 Study of FIT-CD19-CAR-T Cells in R/R B-ALL
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
TriArm Therapeutics (Taiwan) Limited
12 participants
Jul 15, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- 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 Criteria6
- Active central nervous system (CNS) involvement of ALL
- Burkitt's lymphoma or chronic myeloid leukemia (CML) lymphoid blast crisis
- 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
Interventions
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
Administered prior to infusion of ARM011
Administered prior to infusion of ARM011
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07066397