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

Beijing Immunochina Medical Science & Technology

Status and phase

Unknown

Phase 1

Conditions

AML

Treatments

Drug: CAR-T cells

Study type

Interventional

Funder types

Industry

Identifiers

NCT04766840

YMCART202005

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.