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

NCT ID: NCT04766840

Last Updated: 2021-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-12-01

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.

Conditions

AML

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IM73 CAR-T

Drug: IM73 CAR-T Cells

• Fludarabine
• Cyclophosphamide

Group Type: EXPERIMENTAL

CAR-T cells

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

IM73 CAR-T Cells

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Immunochina Medical Science & Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaojun Huang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital (PKUPH)

Beijing, , China

Countries

China

Central Contacts

FEI Wu

Role: CONTACT

wufei@immunochina.com

15801390058

Xiaojun Huang, MD

Role: CONTACT

Other Identifiers

YMCART202005

Identifier Type: -

Identifier Source: org_study_id