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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT02456350
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and B cell lymphoma；
2. Patients with CD19+ B cell malignancies are not able to receive standard treatments and willing to participate in the trial.
3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
4. patients are not eligible for autologous or allogeneic stem-cell transplantation (SCT) or relapsed after autologous or allogeneic stem-cell transplantation；
5. Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease and no longer taking immunosuppressive agents during the treatment.
6. Willing to sign a durable power of attorney；
7. Able to understand and sign the Informed Consent Document；
8. Performance status：ECOG 0-2；
9. Life expectancy：More than 3 months；
10. Patients of both genders must be willing to practice birth control for four months after receiving a lymphodepleting preconditioning regimen；
11. Female participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion, because of the potentially dangerous effects on the fetus；
12. There is no obvious dysfunctions in heart , liver and kidney, and the functions of vital organs are normal；
13. Serology： (1) Seronegative for HIV antibody； (2) Seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV).
14. Hematology： (1) Absolute neutrophil count ≥ 1000/mm3 without support of filgrastim； (2) Platelet count ≥ 50,000/mm3； (3) Hemoglobin \> 8.0g/dL； (4) lymphocyte count ≤ 4000/mm3。
15. Chemistry： (1) AST and ALT ≤ 5 times upper limit of normal； (2) Serum creatinine ≤ 1.6 mg/dl； (3) Bilirubin ≤ 1.5 mg/dl（3.0 mg/dL in patients with Gilbert's syndrome）。
16. More than three weeks must have elapsed since any prior systemic therapy at the time of randomization, and patients' toxicities must have recovered to a grade 1 or less (except for alopecia or vitiligo)；
17. Normal cardiac ejection fraction and no evidence of pericardial effusion as determined by an echocardiogram；
18、More than 30 days must have elapsed since Monoclonal antibody therapy administered prior to apheresis.
Exclusion Criteria:
1. Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression；
2. Patients that have active hemolytic anemia；
3. Patients with detectable cerebrospinal fluid malignant cells or brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases, or any residual intracranial implants；
4. Women of child-bearing potential who are pregnant or breastfeeding；
5. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
6. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
7. Concurrent opportunistic infections；
8. Concurrent Systemic steroid therapy；
9. History of severe immediate hypersensitivity reaction to any of the agents used in this study；
10. Patients with central nervous system (CNS) metastases or symptomatic CNS involvement (including cranial neuropathies or mass lesions)；
11. CNS-3 disease or traumatic spinal tap with POSITIVE Steinherz/Bleyer algorithm with cerebral spinal fluid involvement with malignancy will make any patient not eligible for this protocol；
12. Patients with cardiac atrial or cardiac ventricular lymphoma involvement；
13. Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment；
14. Previous treatment with any gene therapy products.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
85 Years
Study:
NCT02456350
Study Brief:
Protocol Section:
NCT02456350