Clinical trial NCT06128044: CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia, in Relapse
Acute Myeloid Leukemia Refractory
Lead sponsor: Caribou Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 .


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.

Primary outcomes:
measure: (Part A) Number of patients with dose limiting toxicities (DLT)
timeFrame: 28 days
measure: (Part B) Overall Response Rate (ORR)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham (UAB)
state: Alabama
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: The Blood & Marrow Transplant Group of Georgia (BMTGA)
state: Georgia
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (MSKCC)
state: New York
city: Nashville
country: United States
facility: TriStar Bone Marrow Transplant, LLC
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: