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