CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Reason given: Sponsor Decision - Pipeline Reprioritization
Key facts
- Where
- Atlanta, Birmingham, Denver, Houston, Milwaukee, Nashville, New York, Seattle, and Tampa, United StatesSee the 10 sites
- Phase
- Phase 1
Where in United States
- The Blood & Marrow Transplant Group of Georgia (BMTGA)Atlanta, United StatesNo longer taking part
- The University of Alabama at Birmingham (UAB)Birmingham, United StatesNo longer taking part
- Colorado Blood Cancer InstituteDenver, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- TriStar Bone Marrow Transplant, LLCNashville, United StatesNo longer taking part
- Memorial Sloan Kettering Cancer Center MskccNew York, United StatesNo longer taking part
- Weill Cornell Medical CollegeNew York, United StatesNo longer taking part
- Fred Hutchinson Cancer CenterSeattle, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Caribou Biosciences, Inc.
- Trial code
- NCT06128044
- Record updated
- 11 June 2025
- Original description
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 .Read full original descriptionShow less
A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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 .
Inclusion: 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: Prior treatment with CAR-T cell therapy; Allogeneic stem cell transplant within 100 days before lymphodepletion; Known active or prior history of central nervous system involvement; Vaccinated with live, attenuated vaccine within 4 weeks prior to lymphodepletion; Extra-medullary disease (EMD) that is metabolically inactive by 18-FDG PET-CT; Active graft-vs-host disease requiring therapy; Seropositive for or history of human immunodeficiency virus (HIV); 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; Acute promyelocytic leukemia.