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

NCT07144020 | Recruiting Early Phase 1

• 1 other identifier: TXB2024010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia

Keywords

CD117 CAR-T

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Up to 28 days after Treatment

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after Treatment

Secondary Outcomes (4)

• Complete response (CR), and complete response with incomplete hematologic recovery (CRi)

  Up to 12 weeks after CAR-T infusion

• Duration of remission ,DOR

  Up to 1 years after CAR-T infusion

• Overall survival, OS

  Up to 1 years after CAR-T infusion

• Leukemia-Free Survival, LFS

  Up to 2 years after Treatment

Study Arms (1)

CAR-T cells（ chimeric antigen receptor T cells）

EXPERIMENTAL

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

Biological: CD117 CAR T-cells

Interventions

CD117 CAR T-cells BIOLOGICAL

Each subject receive CD117 CAR T-cells by intravenous infusion

Also known as: CD117 CAR T-cells injection

CAR-T cells（ chimeric antigen receptor T cells）

Eligibility Criteria

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

You may qualify if:

• \. Patients with a histologically or immunophenotypically confirmed diagnosis of CD117-positive Acute Myeloid Leukemia (AML).
• \. 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.
• \. Presence of \>5% bone marrow blasts (by morphology) and/or \>1% (by flow cytometric analysis).
• \. Total bilirubin ≤1.5 × ULN (≤51 μmol/L) ALT and AST ≤3 × ULN Serum creatinine ≤1.5 × ULN (≤176.8 μmol/L)
• \. Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
• \. Oxygen saturation ≥92% on room air.
• \. Life expectancy ≥3 months.
• \. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• \. 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).
• \. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.

You may not qualify if:

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

Sponsors & Collaborators

• Zhejiang University: lead
• Yake Biotechnology Ltd.: collaborator

Study Sites (1)

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• He Huang, MD

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

He Huang, MD

CONTACT

057187233772; hehuangyu@126.com

Yongxian Hu, MD

CONTACT

057187233772; huyongxian2000@aliyun.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): September 5, 2028
• Study Completion (Estimated): September 5, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)