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

Inclusion Criteria:

1. Documented diagnosis of AML with either refractory or relapsed disease,
2. Non-proliferative disease
3. 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)
4. No available therapy with reasonable survival benefit
5. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 and fit for allogeneic stem cell transplant
6. Adequate renal, hepatic, pulmonary, and cardiac function, with specific laboratory criteria
7. 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:

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

Other inclusion and exclusion criteria may apply.