Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT03473457
Eligibility Criteria:
Inclusion Criteria:
1. Relapsed/Refractory AML patients
2. Positive for any of CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.(cytology, genetic testing)
3. Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky Performance Status（KPS) score is more than 80.
4. No cytapheresis and cell separation contraindication.
5. Hemoglobin is more than 80 gram per litre.
6. The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times the upper limit of normal;(4)Alanine transaminase（ALT）and glutamic-oxalacetic transaminase（AST）is less than 3 times the upper limit of normal,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
7. After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
8. Volunteered for this clinical trail and signed a consent form .
9. Currently, chemotherapy and approved targeted therapies are ineffective for the patients.Or patients cannot tolerate current chemotherapy.
Exclusion Criteria:
1. Active other disease and cannot control after treatment.
2. Patients with actively infection of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
3. Severe psychiatric disorder or other disease in central nervous system.
4. Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
5. Patients with infection of HIV .
6. Pregnant or lactating women.
7. Patients who have Graft-Versus-Host Disease (GVHD) should receive systemic administration of immunosuppressive agents.
8. Patients have received other genetic therapy products.
9. Patients who have received systemic administration of glucocorticoid agents in one week before CART therapy.
10. Any situation may do harm to the subjects or interfere the results.
11. Have had Prolonged QT interval or severe heart disease in the past.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT03473457
Study Brief:
Protocol Section:
NCT03473457