NCT05445011 Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the Treatment of Relapsed / Refractory Acute Myeloid Leukemia
| NCT ID | NCT05445011 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2022-06-14 |
| Primary Completion | 2025-06-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 12 participants in total. It began in 2022-06-14 with a primary completion date of 2025-06-14.
⚠ 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
This is a clinical trial of Anti-FLT3 CAR-T Cell (TAA05 Cell Injection) in the treatment of patients with relapsed / refractory acute myeloid leukemia. The purpose is to evaluate the safety and efficacy of anti-FLT3 CAR-T cells in patients with relapsed / refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 \~ 70 years old (including boundary value), regardless of gender; 2. FLT-3 positive acute myeloid leukemia; 3. The expected survival time was more than 3 months; 4. ECOG score 0-2; 5. Refractory or relapsed AML patients after standardized treatment who meet any of the following criteria: 1. After complete remission (CR), there were ≥5% leukemia cells or blast cells in the bone marrow(except for other reasons such as bone marrow regeneration after consolidation chemotherapy)in the peripheral blood and extramedullary lesions; 2. Naive patients who are treated with 2 courses of treatment and are ineffective; 3. Those who have relapsed within 12 months after CR after consolidation and intensive treatment; 4. Those who relapse after 12 months but are ineffective after conventional chemotherapy; 5. Subjects who experienced relapses twice or multiple times; with persistent extramedullary leukemia. 6. Kidney function, cardiopulmonary function, liver function, and coagulation function meet the following requirements: 1. Creatinine ≤ 1.5 ULN; 2. Left ventricular ejection fraction ≥ 50% and echocardiography does not reveal pericardial effusions and ECG does not reveal clinically significant abnormal bands; 3. Blood oxygen saturation \> 92%; 4. Total bilirubin ≤ 2 × ULN; ALT and AST ≤ 2.5 × ULN; for the patients with ALT and AST abnormalities caused by disease which researchers judge (e.g. liver infiltrates or bile duct obstruction), the indicators of which can be relaxed to ≤5× ULN; 5. PT/INR and PTT ≤ 1.5 ULN; 7. Patients understand the trial and have signed the informed consent form. Exclusion Criteria: 1. Patients with malignant tumors other than acute myeloid leukemia within 5 years before the screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after the radical operation, and breast ductal carcinoma in situ after radical operation; 2. Patients with hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference range; Hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody-positive; Cytomegalovirus (CMV) DNA positive; Syphilis test positive; 3. Patients with severe heart disease: including but not limited to unstable angina pectoris, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \[NYHA\] classification ≥ grade III), severe arrhythmia; 4. Patients with unstable systemic diseases judged by the researcher: including but not limited to severe liver, kidney, or metabolic diseases requiring drug treatment; 5. Within 7 days before screening, there were active or uncontrollable infections requiring systemic treatment (except mild urogenital infection and upper respiratory tract infection); 6. Pregnant or lactating women, female subjects who planned pregnancy within 2 years after cell reinfusion, or male subjects whose partners planned pregnancy within 2 years after cell reinfusion; 7. Subjects who were receiving systemic steroid treatment within 7 days before screening or who were determined by the investigator to need long-term systemic steroid treatment during treatment (except inhalation or local use); 8. Participated in other clinical studies within 1 month before screening; 9. There was evidence of central nervous system invasion during subject screening(e.g. detection of tumor cells in cerebrospinal fluid or imaging suggests central infiltrates;); 10. Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive agents; 11. Patients with a history of epilepsy or other central nervous system disorders; 12. Patients with primary immunodeficiency diseases; 13. Patients who are not suitable for cell construction judged by researchers; 14. Other situation researchers believe that it is not suitable for inclusion.
Contact & Investigator
Heng Mei
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT05445011 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, 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 NCT05445011 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 NCT05445011 currently recruiting?
Yes, NCT05445011 is actively recruiting participants. Contact the research team at hmei@hust.edu.cn for enrollment information.
Where is the NCT05445011 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05445011 clinical trial?
NCT05445011 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Heng Mei at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 12 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.