CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia RefractoryAcute Myeloid Leukemia, in Relapse
- Interventions
- Drug: CB-012
- Registration Number
- NCT06128044
- Lead Sponsor
- Caribou Biosciences, Inc.
- 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 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 .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation of CB-012 CB-012 Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified. Dose Expansion of CB-012 CB-012 Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D.
- Primary Outcome Measures
Name Time Method (Part A) Number of patients with dose limiting toxicities (DLT) 28 days Number of patients with DLTs during the 28 days following the first administration of CB-012.
(Part B) Overall Response Rate (ORR) 12 months The ORR will be evaluated by European Leukemia Net (ELN) criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
The University of Alabama at Birmingham (UAB)
🇺🇸Birmingham, Alabama, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, 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
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