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

Stopped early · Phase 1

Conditions studied: Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory

In brief

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 .

Key facts

Study ID

NCT06128044

Run by

Caribou Biosciences, Inc.

People needed

12

Starts

2024-02-08

Expected to finish

2025-05-30

Last updated by the study team

2025-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• The Blood & Marrow Transplant Group of Georgia (BMTGA) — Atlanta, Georgia, United States
• Weill Cornell Medical College — New York, New York, United States
• Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States
• TriStar Bone Marrow Transplant, LLC — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Fred Hutchinson Cancer Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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