Donor-derived CAR-T Cells in the Treatment of AML Patients

Study Overview
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Brief Summary
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This is a clinical study to evaluate the safety and efficacy of donor-derived CAR-T cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in China.

Detailed Description
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This is a single-center, single-arm, open-label study. This study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and CAR-T cells manufacture. Donor-derived CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.

Official Title
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A Study to Evaluate the Safety and Efficacy of Donor-derived CAR-T Cells in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia

Conditions
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AML

Intervention / Treatment
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* Drug: CAR-T cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Refractory or relapsed AML patients. Have found an appropriate matched donor for CAR-T cells manufacturing. Patients must have evaluable evidence of disease. Age ≥ 18 years; Expected survival is more than 3 months. ECOG score 0-2 points. Women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up. Adequet liver, kidney, heart and lung function. Exclusion Criteria: Confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia. Patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases. Prior use of any gene therapy product. History of epilepsy or other central nervous system diseases. Presence of concurrent active malignancy. Active hepatitis B or C virus, patients with HIV or syphilis infection. Currently participating in or having participated in other drug clinical trials during past 30 days. Active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment. Other situations not suitable for the study judged by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IM73 CAR-T<br>Drug: IM73 CAR-T Cells Fludarabine Cyclophosphamide | Drug: CAR-T cells<br>* Drug: IM73 CAR-T Cells Drug: Fludarabine Two days before cell infusion, patient will be treated with fludarabine for 3 days Drug: Cyclophosphamide: Two days before cell infusion, patient will be treated with Cyclophosphamide for 3 days<br>* Other names: IM73 CAR-T Cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity | ≥ Grade 4 adverse event related to CAR-T cells infusion | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T, Immunotherapy