Tests donor-derived CD117 CAR-T cells in adults with relapsed or resistant acute myeloid leukemia
Tests donor-derived CD117 CAR-T cells in adults with returned leukemia.
Plain-language title generated from the registry record
Registry title: Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with CD117-positive acute myeloid leukemia (AML) that has come back or did not respond to treatment, with no other standard options or trials available.
- Age
- 18 years and older.
- Sex
- All sexes can join.
- Disease stage
- CD117-positive AML that has relapsed or is refractory (did not respond to treatment). Bone marrow blasts above 5% by morphology and/or above 1% by flow cytometry.
- Earlier treatment
- Must not have used any gene therapy product before. Refractory disease includes failing to reach complete remission after two cycles of standard induction therapy.
- Biomarker or test result
- CD117-positive leukemia, confirmed by tissue or immunophenotype testing.
Main reasons for not taking part
- History of epilepsy or other central nervous system disease
- Prolonged QT interval or severe heart disease
- Active infection that cannot be treated, including active hepatitis B or C
- Infected with the AIDS virus (HIV)
- Other uncontrolled disease that the researchers think makes joining unsuitable
Read by machine on 12 November 2026.
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaContact: He Huang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhejiang University
- Trial code
- NCT07144020
- Record updated
- 27 August 2025
- Original description
A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid LeukemiaRead full original descriptionShow less
Donor Derived CD117 CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
Inclusion: 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: 5. Before using any gene therapy products; 1. Patients with the history of epilepsy or other CNS disease; 3. Active infection with no cure; 4. Active infection of hepatitis B virus or C virus ; 7. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining; 8. Infected with AIDS virus; 2. Patients with prolonged QT interval time or severe heart disease; 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.