Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Conditions
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 .
Interventions
DRUGCB-012
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
Sponsors
Caribou Biosciences, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (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 |
Countries
United States
Outcome results
None listed