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

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

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

Conditions2

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