Clinical trial · Interventional
CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor Decision - Pipeline Reprioritization
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia, in Relapse | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Acute Myeloid Leukemia Refractory | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CB-012 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose Escalation of CB-012
- description
- 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.
- interventionNames
- Drug: CB-012
- type
- EXPERIMENTAL
- label
- Dose Expansion of CB-012
- description
- 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.
- interventionNames
- Drug: CB-012
Primary outcomes (2)
- measure
- (Part A) Number of patients with dose limiting toxicities (DLT)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available