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:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT05333302
Eligibility Criteria:
Inclusion Criteria:
* CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
* Karnofsky or Lansky performance scale greater or equal to 70;
* T-cells count in peripheral blood \>150 cells/µL;
* Written informed consent.
Exclusion Criteria:
* primary immunodeficiencies or genetic syndromes;
* neurologic diseases;
* autoimmune diseases or polyallergie;
* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
* GvHD grade 2-4;
* uncontrolled systemic infection;
* hypoxia (Sp02\<90%)
* severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age;
* renal dysfunction: serum creatinine level \>=3x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
* pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
30 Years
Study:
NCT05333302
Study Brief:
Protocol Section:
NCT05333302