AML
Conditions
Keywords
CAR-T, Immunotherapy
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.
Interventions
DRUGCAR-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
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity | 28 days | ≥ Grade 4 adverse event related to CAR-T cells infusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 28 days | Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion |
Countries
China
Contacts
Primary ContactFEI Wu
Backup ContactXiaojun Huang, MD
Outcome results
None listed