Status:
UNKNOWN
Donor-derived CAR-T Cells in the Treatment of AML Patients
Lead Sponsor:
Beijing Immunochina Medical Science & Technology Co., Ltd.
Conditions:
AML
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04766840
Start Date
March 1 2021
End Date
December 1 2023
Last Update
February 23 2021
Active Locations (1)
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1
Peking University People's Hospital (PKUPH)
Beijing, China