CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Inclusion Criteria

• 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.

Exclusion Criteria

• Acute promyelocytic leukemia
• Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT
• Prior treatment with CAR-T cell therapy
• Allogeneic stem cell transplant within 100 days before lymphodepletion
• Active graft-vs-host disease requiring therapy
• Known active or prior history of central nervous system involvement
• Seropositive for or history of human immunodeficiency virus (HIV)
• Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion
• Active hepatitis B or C infection
• Primary immunodeficiency or autoimmune disease
• Known life-threatening allergies, hypersensitivity, or intolerance to CB-012 or its excipients Other inclusion and exclusion criteria may apply.