Donor-derived CAR-T Cells in the Treatment of AML Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IM73 CAR-T Drug: IM73 CAR-T Cells Fludarabine Cyclophosphamide |
Drug: CAR-T cells
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dose limiting toxicity [28 days]
≥ Grade 4 adverse event related to CAR-T cells infusion
Secondary Outcome Measures
- Objective response rate [28 days]
Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital (PKUPH) | Peking | China |
Sponsors and Collaborators
- Beijing Immunochina Medical Science & Technology Co., Ltd.
Investigators
- Principal Investigator: Xiaojun Huang, MD, Peking University People's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YMCART202005