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

AML Clinical Trial

Official title:

A 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04766840
• Other study ID #: YMCART202005
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2021
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: FEI Wu
• Phone: 15801390058
• Email: wufei[@]immunochina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• AML

Intervention

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

Locations

Country	Name	City	State
China	Peking University People's Hospital (PKUPH)	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Immunochina Medical Science & Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity	= Grade 4 adverse event related to CAR-T cells infusion	28 days
Secondary	Objective response rate	Patients who achieve CR(complete response) or CRi 28 days after CAR-T cells infusuion	28 days