Clinical trial · Interventional
Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia
Donor Derived CD117 CAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
NCT07144020CI-TRIAL-00094158recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD117 CAR T-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR-T cells( chimeric antigen receptor T cells)
- description
- Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
- interventionNames
- Biological: CD117 CAR T-cells
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 28 days after Treatment
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- Up to 2 years after Treatment
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.