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

Phase 1

• Conditions: AML
• Interventions: Drug: CAR-T cells

• Registration Number: NCT04766840
• Lead Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.

Brief Summary

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

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.

Study Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Study First Posted: 2021-02-23
• Last Update Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2023-06-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IM73 CAR-T	CAR-T cells	Drug: IM73 CAR-T Cells * Fludarabine * Cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity	28 days	≥ Grade 4 adverse event related to CAR-T cells infusion

Secondary Outcome Measures

Name	Time	Method
Objective response rate	28 days	Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion

Trial Locations

Locations (1)

Peking University People's Hospital (PKUPH); 🇨🇳 Peking, China