CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
18 Years and older, Male and Female
CB12A (primary)
NCI-2024-01081
Summary
CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets
C-type lectin-like molecule-1 (CLL-1). This is a Phase 1 study to evaluate the safety,
preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults
with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or
did not respond or is no longer responding to other treatment (refractory). Participants
must have received at least 1 but not more than 3 prior lines of treatment for AML .
Eligibility
- Documented diagnosis of AML with either refractory or relapsed disease,
- Non-proliferative disease
- No more than 3 prior lines of therapy (induction, consolidation with or without allogeneic stem cell transplant, and maintenance are considered 1 line of therapy)
- No available therapy with reasonable survival benefit
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
- Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
- Women of child-bearing potential and men with a female partner who has child-bearing potential must agree to use acceptable, effective methods of birth control.
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