Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia

NCT ID: NCT07144020

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-05
• Study Completion Date: 2028-09-05

Brief Summary

A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia

Detailed Description

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD117 CAR-T Cell in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 15-50 participants in this trial.

Conditions

Acute Myeloid Leukemia

Study Design

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

Study Groups

CAR-T cells（ chimeric antigen receptor T cells）

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Group Type: EXPERIMENTAL

CD117 CAR T-cells

Intervention Type: BIOLOGICAL

Each subject receive CD117 CAR T-cells by intravenous infusion

Interventions

CD117 CAR T-cells

Each subject receive CD117 CAR T-cells by intravenous infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

CD117 CAR T-cells injection

Eligibility Criteria

Inclusion Criteria

• 1. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).
• 2. Diagnosis must meet the 2016 WHO classification criteria for AML and fulfill the definitions for relapsed or refractory disease per the *Chinese Guidelines for the Diagnosis and Management of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)*, with no available suitable standard therapeutic options or registered clinical trials.
• a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count >5% (when assessed morphologically, after excluding regenerative changes post-consolidation chemotherapy), or development of extramedullary disease after achieving a Complete Remission (CR).
• b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed patients; relapse within 12 months after CR following consolidation therapy; relapse beyond 12 months that fails to respond to conventional salvage chemotherapy; ≥2 relapses; or persistent extramedullary leukemia.
• 3. Presence of >5% bone marrow blasts (by morphology) and/or >1% (by flow cytometric analysis).
• 4. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)
• 5. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
• 6. Oxygen saturation ≥92% on room air.
• 7. Life expectancy ≥3 months.
• 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• 9. For patients of childbearing potential: Agreement to use highly effective contraception from screening, throughout the study treatment period, and for at least 6 months after the cell infusion (due to unknown risks to the fetus).
• 10. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.

Exclusion Criteria

• 1. Patients with the history of epilepsy or other CNS disease;
• 2. Patients with prolonged QT interval time or severe heart disease;
• 3. Active infection with no cure;
• 4. Active infection of hepatitis B virus or C virus ;
• 5. Before using any gene therapy products;
• 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
• 7. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining;
• 8. Infected with AIDS virus;
• 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

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

Sponsors

Yake Biotechnology Ltd.

INDUSTRY

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

He Huang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

He Huang, MD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

He Huang, MD

Role: CONTACT

hehuangyu@126.com

057187233772

Yongxian Hu, MD

Role: CONTACT

huyongxian2000@aliyun.com

057187233772

Facility Contacts

He Huang, MD

Role: primary

hehuangyu@126.com

057187233772

Yongxian Hu, MD

Role: backup

huyongxian2000@aliyun.com

057187233772

Other Identifiers

TXB2024010

Identifier Type: -

Identifier Source: org_study_id