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New treatment option for Acute Myeloid Leukemia
Official title Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT07144020
What this study is testing
What is CD117 CAR T-cells?
CD117 CAR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as CD117 CAR T-cells injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- a). Relapsed AML: Defined as the reappearance of leukemic blasts in the peripheral blood, bone marrow blast count \>5% (when assessed...
- b). Refractory AML (meeting at least one criterion): Failure to achieve CR following two cycles of standard induction therapy in newly diagnosed...
- 3\. Presence of \>5% bone marrow blasts (by morphology) and/or \>1% (by flow cytometric analysis).
You likely can't join if
- 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;
See the full eligibility 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...
- 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...
- 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...
- 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...
- 10\. Voluntary participation, understanding of the study procedures, and provision of written informed consent by the patient or their legally authorized representative.
- 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 people or interfere with the trial results.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.