AMpLify: CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Study Details
Study Description
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 .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose Escalation of CB-012 Part A (Dose Escalation) of CB-012 with increasing doses using a 3+3 design, during which the MTD and/or RDE will be identified. |
Drug: CB-012
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
Other Names:
|
| Experimental: Dose Expansion of CB-012 Part B (Dose Expansion) - participants will be enrolled to receive CB-012 at the RDE and/or MTD determined in Part A in order to the determine the RP2D. |
Drug: CB-012
CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion
Other Names:
|
Outcome Measures
Primary Outcome Measures
- (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
Eligibility Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Caribou Biosciences, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CB12A