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

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).

CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). CB-012 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).

CB-012 infusion will be administered through an IV tube.

Participants are expected to be in the study for approximately two years and one month.

Key Eligibility:

Inclusion Criteria:

Documented diagnosis of acute myeloid leukemia (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)
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.

Detailed eligibility will be discussed when reaching out to the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Tania J. Curcio, NP, FNP-BC
(212) 746-2571
tjc9003@med.cornell.edu

Primary Investigator(s)

Gail J Roboz, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2401026953

ClinicalTrials.gov:

NCT06128044

Status

Open to Enrollment

Age Group

Adult

Disease

Leukemia

Acute Myeloid Leukemia