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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: AML
• Intervention / Treatment: Drug: CAR-T cells

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 Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: FEI Wu; Phone Number: 15801390058; Email: wufei@immunochina.com

Study Locations

• China
  • Peking, China
    • Peking University People's Hospital (PKUPH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: IM73 CAR-T Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicity	≥ Grade 4 adverse event related to CAR-T cells infusion	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	Patients who achieve CR（complete response） or CRi 28 days after CAR-T cells infusuion	28 days

Collaborators and Investigators

• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Investigators: Principal Investigator: Xiaojun Huang, MD, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: February 19, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 23, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: CAR-T; Immunotherapy
• Other Study ID Numbers: YMCART202005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No