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

NCT04766840 | Unknown Phase 1

• 1 other identifier: YMCART202005
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

AML

Keywords

CAR-T; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity

  ≥ Grade 4 adverse event related to CAR-T cells infusion

  28 days

Secondary Outcomes (1)

• Objective response rate

  28 days

Study Arms (1)

IM73 CAR-T

EXPERIMENTAL

Drug: IM73 CAR-T Cells * Fludarabine * Cyclophosphamide

Drug: CAR-T cells

Interventions

CAR-T cells 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

Also known as: IM73 CAR-T Cells

IM73 CAR-T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Immunochina Medical Science & Technology Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital (PKUPH)

Beijing, China

Location

MeSH Terms

Interventions

Immunotherapy, Adoptive

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Xiaojun Huang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FEI Wu

CONTACT

15801390058; wufei@immunochina.com

Xiaojun Huang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 23, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)