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

Acute Myeloid Leukemia, in Relapse Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128044
• Other study ID #: CB12A
• Status: Recruiting
• Phase: Phase 1
• Start date: February 8, 2024
• Est. completion date: April 2028

Study information

• Verified date: January 2024
• Source: Caribou Biosciences, Inc.
• Contact: Caribou Biosciences
• Phone: 510-982-6030
• Email: clinicaltrials[@]cariboubio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2028
• Est. primary completion date: November 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia Refractory
• Acute Myeloid Leukemia, in Relapse
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• CB-012
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Locations

Country	Name	City	State
United States	The Blood & Marrow Transplant Group of Georgia (BMTGA)	Atlanta	Georgia
United States	The University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas
United States	TriStar Bone Marrow Transplant, LLC	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center (MSKCC)	New York	New York
United States	Fred Hutchinson Cancer Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Caribou Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(Part A) Number of patients with dose limiting toxicities (DLT)	Number of patients with DLTs during the 28 days following the first administration of CB-012.	28 days
Primary	(Part B) Overall Response Rate (ORR)	The ORR will be evaluated by European Leukemia Net (ELN) criteria	12 months