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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03638206
Eligibility Criteria:
Inclusion Criteria:
1. If patients had receive immunotherapy, they should reach PR/NR, or recurrency.
2. Patients must be willing to sign an informed consent.
3. age: 4 to 70 years
4. Estimated survival of ≥ 12 weeks, but ≤ 2 years
5. Blood tumor or solid tumor was diagnosed by histopathology.Positive expression of CD19, CD22, CD33, CD38, BCMA, NY-ESO-1, c-met, Mesothelin, CEGFRvIII and DR5 was confirmed by biopsy IHC test or flow cytometry test. If NY-ESO-1 is positive expression ,positive HLA-A\*0201 is required at the same time .
6. Subjects with solid tumor must have measureable disease
7. Routine blood test：hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
8. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
9. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV(patients with liver cancer were excluded)
10. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
11. ECOG score ≤2
12. Adequate venous access for apheresis, and no other contraindications for leukapheresis
13. Women of child-bearing age must have evidence of negative pregnancy test.
14. Subjects of reproductive potential must agree to use acceptable birth control methods within 1 year after treatment, as described in protocol.
Exclusion Criteria:
1. ECOG \>= 3
2. Patients with history of T cell tumors
3. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
4. Acute or chronic GVHD after allogeneic hematopoiesis
5. steroid hormoneswere used before and after blood collection and infusion
6. HIV infection or active hepatitis B or hepatitis C infection
7. Uncontrolled active infection
8. Enrolled to other clinical study in the last 4 weeks.
9. Subjects with systemic auto-immune disease or immunodeficiency.
10. Subjects with CNS diseases.
11. Other patients that researchers considered unsuitable for inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
70 Years
Study:
NCT03638206
Study Brief:
Protocol Section:
NCT03638206