Status:
TERMINATED
CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Lead Sponsor:
Caribou Biosciences, Inc.
Conditions:
Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 pha...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06128044
Start Date
February 8 2024
End Date
May 30 2025
Last Update
June 11 2025
Active Locations (10)
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1
The University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35249-0001
2
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
4
The Blood & Marrow Transplant Group of Georgia (BMTGA)
Atlanta, Georgia, United States, 30342