NCT06762132 A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT06762132 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Zhejiang University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-10-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2025-01-10 with a primary completion date of 2027-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Clinical Study on the Safety and Effectiveness of targeting CD33 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
Eligibility Criteria
Inclusion 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 cannot reinfusion); * 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 relapsed and refractory acute myeloid leukemia (2017 edition)", and currently there are no clinically relevant treatments or suitable clinical trials for registration: * 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 after consolidation chemotherapy) or leukemia cell infiltration appears outside the bone marrow; * 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 treatment after CR; Patients who relapse after 12 months but fail conventional chemotherapy; Patients with 2 or more relapses; Persistent extramedullary leukemia; * 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; 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.
Contact & Investigator
He Huang, MD
PRINCIPAL INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Frequently Asked Questions
Who can join the NCT06762132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06762132 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06762132 currently recruiting?
Yes, NCT06762132 is actively recruiting participants. Contact the research team at hehuangyu@126.com for enrollment information.
Where is the NCT06762132 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06762132 clinical trial?
NCT06762132 is sponsored by Zhejiang University. The principal investigator is He Huang, MD at First Affiliated Hospital of Zhejiang University. The trial plans to enroll 27 participants.
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