Skip to content
TrialMatch
Sign up
Recruiting Early Phase 1

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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

Condition
Acute Myeloid Leukemia
Tested
CD117 CAR T-cells
Sponsor
Zhejiang University

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Study condition: Acute Myeloid Leukemia
  • 1\. 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).
  • 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 9

  • 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.

Where

1 site, 1 recruiting

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.