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:
NCT03265106
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
* CD19+ leukemia or lymphoma
* Not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor
* Follicular lymphoma, previously identified as CD19+:
* Disease responding or stable after most recent therapy (chemotherapy, MoAb, etc)
* ECOG result is 0, 1 or 2.
* With normal heart, liver and kidney functions.
* Negative serum DNA for EBV and CMV; negative antigen for HBV; negative serum antibody for HCV, HIV and syphilis.
* Negative in pregnancy test (female subject only).
Exclusion Criteria:
* ECOG result is 3, 4 or 5.
* Pregnant or lactating female
* Uncontrolled active infection
* Active hepatitis B or hepatitis C infection
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
* Previously treatment with any gene therapy products
* HIV infection
* Enrolled to other clinical study in the last 4 weeks.
* Subjects with systemic auto-immune disease or immunodeficiency.
* Subjects with CNS diseases.
* Subjects with secondary tumors.
* Subjects with tumor infiltration in liver, brain or GI tract.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
18 Years
Study:
NCT03265106
Study Brief:
Protocol Section:
NCT03265106