BridgeMD
Tests treatment safety and results for Acute Myeloid Leukemia
Official title A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06762132
What this study is testing
What is CD33 CAR T-cells?
CD33 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 CD33 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 targeting CD33 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\. Male or female, age ≥ 18 years old;
- 2\. CAR-T cells can be prepared normally, or who have failed to prepare autologous CAR-T cells (including the number of autologous lymphocytes...
- 3\. Patients diagnosed with CD33 positive acute myeloid leukemia (AML) through histological or immunological examination，and CD33 positive expression...
- 4\. Complies with the 2016 WHO classification for AML diagnosis and meets the diagnostic criteria for recurrence and refractory acute myeloid...
- a) Diagnostic criteria for recurrent AML: After complete remission (CR), leukemia cells reappear in peripheral blood or primitive cells in bone...
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\. Male or female, age ≥ 18 years old;
- 2\. CAR-T cells can be prepared normally, or who have failed to prepare autologous CAR-T cells (including the number of autologous lymphocytes \<1×10\^9 or the expansion during the preparation process is insufficient or...
- 3\. Patients diagnosed with CD33 positive acute myeloid leukemia (AML) through histological or immunological examination，and CD33 positive expression rate \>80%;
- 4\. Complies with the 2016 WHO classification for AML diagnosis and meets the diagnostic criteria for recurrence and refractory acute myeloid leukemia in the "Chinese Guidelines for the Diagnosis and Treatment of...
- a) Diagnostic criteria for recurrent AML: After complete remission (CR), leukemia cells reappear in peripheral blood or primitive cells in bone marrow\>0.050 (excluding other reasons such as bone marrow regeneration...
- b) Diagnostic criteria for refractory AML: initial treatment cases that have failed to respond to two courses of standard protocol treatment; Patients who relapse within 12 months after consolidation and intensive...
- 5\. The number of primitive cells (promyelocytes and/or promyelocytes) in the bone marrow \> 5% (morphology) and/or \> 1% (flow cytometry detection);
- 6\. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times of the upper limit of normal value, serum creatinine ≤ 176.8 μmol / L；
- 7\. Echocardiography shows left ventricular ejection fraction (LVEF) ≥ 50%;
- 8\. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%;
- 9\. The estimated survival time is more than 3 months;
- 10\. ECOG score was 0-2;
- 11\. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
- 12\. Those who voluntarily participated in this trial and provided informed consent;
- 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.