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 @ 12:18 PM
Ignite Modification Date:
2025-12-24 @ 12:18 PM
NCT ID:
NCT04204161
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
1. no available curative treatment options (such as autologous or allogeneic SCT)
2. If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
3. Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
4. Patients must be willing to sign an informed consent.
5. Age:≤18 years.
6. survival\>12 weeks
7. Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
8. Routine blood test:hemoglobin\>=90 g/L; platelet\>=50×10\^9/L.
9. Liver function: ALT and AST≤2.5 (ULN) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 ULN), bilirubin \<2.0 mg/dl.
10. Renal function:BUN: 9-20mg / dl; serum creatinine\<= 1.5 times upper limits of normal; endogenous creatinine clearance rate\>=50 ml/min
11. Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
12. Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)\>=55%.
13. ECOG score ≤2。
14. Adequate venous access for apheresis, and no other contraindications for leukapheresis
Exclusion Criteria:
1. ECOG \>= 3.
2. Patients with history of T cell tumors .
3. organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
4. Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
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. Allergic to cytokines.
11. Definite neuropathic or psychotic patients, including authors of dementia or seizures, history of psychotropic substance abuse and unable to quit, or other substantial lesions that may increase central neurotoxicity.
12. Patients with malignant tumors of the central nervous system.
13. Lung, brain or intestinal tumor infiltrates.
14. The second tumor was found.
15. Allergic to cytokine antagonists.
16. Other patients that researchers considered unsuitable for inclusion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
18 Years
Study:
NCT04204161
Study Brief:
Protocol Section:
NCT04204161