Tests CD33 CAR-T cell therapy in relapsed or refractory acute myeloid leukemia
Tests modified immune cells targeting CD33 in adults with returning acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with CD33-positive acute myeloid leukemia (AML) that came back or did not respond to treatment. People can join only if no other clinically relevant treatment or clinical trial is available to them. Participants get CD33 CAR-T cells, which are immune cells changed in a lab to attack the leukemia.
- Age
- 18 years and older
- Sex
- Men and women can join. People who can have children must agree to use effective birth control until at least 6 months after the last cell infusion.
- Disease stage
- AML that came back (relapsed) or did not respond to treatment (refractory), based on the 2016 WHO classification and the 2017 Chinese guidelines. Relapsed means leukemia cells return after complete remission: in the blood, as bone marrow blasts >0.050, or outside the bone marrow. Refractory means one of these: no response to two courses of standard treatment, relapse within 12 months after consolidation treatment, relapse after 12 months with failed usual chemotherapy, 2 or more relapses, or leukemia that stays outside the bone marrow. Immature leukemia cells (blasts) in the bone marrow must be > 5% (microscope) and/or > 1% (flow cytometry). ECOG score 0-2, meaning you can care for yourself. Expected survival must be more than 3 months. Total bilirubin ≤ 51 μmol / L, ALT and AST ≤ 3 times the upper limit of normal, serum creatinine ≤ 176.8 μmol / L. Heart pumping strength (LVEF) ≥ 50% on heart ultrasound. No active lung infection and oxygen level more than 92% when breathing normal air.
- Earlier treatment
- You cannot join if you have ever had any gene therapy product. CAR-T cells must be possible to make from your own cells, or making them from your own cells must have failed (for example, own lymphocytes <1×10^9, or the cells did not grow enough).
- Biomarker or test result
- The leukemia must be CD33 positive, with a CD33 positive rate >80%. Your T cells must grow at least 5 times in response to CD3/CD28 stimulation in the lab.
Main reasons for not taking part
- History of epilepsy or other disease of the brain and spinal cord
- Prolonged QT interval on heart tracing or severe heart disease
- Active infection that cannot be treated, active hepatitis B or C, or HIV infection
- Any gene therapy product used before
- Other uncontrolled diseases that the researchers think make joining unsafe
Read by machine on 12 November 2026.
Where in China
- The first affiliated hospital of medical college of zhejiang universityHangzhou, ChinaContact: He Huang, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhejiang University
- Trial code
- NCT06762132
- Record updated
- 7 January 2025
- Original description
A Clinical Study on the Safety and Effectiveness of targeting CD33 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid LeukemiaRead full original descriptionShow less
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
A Clinical Study on the Safety and Effectiveness of targeting CD33 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
Inclusion: 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: 5. Before using any gene therapy products; 1. Patients with the history of epilepsy or other CNS disease; 3. Active infection with no cure; 4. Active infection of hepatitis B virus or C virus ; 7. Suffering from other uncontrolled diseases that the researchers consider unsuitable for joining; 8. Infected with AIDS virus; 2. Patients with prolonged QT interval time or severe heart disease; 6. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; 9. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.