CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2025-05-30

Brief Summary

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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 .

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Detailed Description

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Conditions

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Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CB-012

Intervention Type DRUG

CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

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.

Group Type EXPERIMENTAL

CB-012

Intervention Type DRUG

CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Interventions

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CB-012

CB-012 allogeneic CAR-T cell therapy targeting CLL-1 Cyclophosphamide and Fludarabine chemotherapy for lymphodepletion

Intervention Type DRUG

Other Intervention Names

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Cyclophosphamide Fludarabine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No