Acute Myeloid Leukemia Clinical Trial

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

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 .

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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 is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06128044

Recruitment Status:

Recruiting

Sponsor:

Caribou Biosciences, Inc.

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There are 6 Locations for this study

See Locations Near You

The University of Alabama at Birmingham (UAB)
Birmingham Alabama, 35249, United States More Info
Daniel Robertson
Contact
205-644-2591
[email protected]
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States More Info
New Patient Contact
Contact
720-754-4835
[email protected]
The Blood & Marrow Transplant Group of Georgia (BMTGA)
Atlanta Georgia, 30342, United States More Info
Caitlin Guzowski
Contact
404-851-8523
[email protected]
Memorial Sloan Kettering Cancer Center (MSKCC)
New York New York, 10065, United States More Info
Dr. Jae Park
Contact
646-608-2091
[email protected]
TriStar Bone Marrow Transplant, LLC
Nashville Tennessee, 37203, United States More Info
Nardin Hanna
Contact
615-987-1891
[email protected]
MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Resa Knott
Contact
281-684-8780
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT06128044

Recruitment Status:

Recruiting

Sponsor:


Caribou Biosciences, Inc.

How clear is this clinincal trial information?

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