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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT05252403
Eligibility Criteria:
Inclusion Criteria:
Children (1-17) and adults (18-75 years old);
* Relapsed or refractory adult and pediatric B- ALL as defined for the presence of bone marrow with ≥ 5% lymphoblasts by morphologic assessment, or if \<5%, with at least 1% of molecular disease at PCR;
* Evidence of CD19 tumor expression in bone marrow and/or peripheral blood by flow cytometry;
* Diagnosis of CD19 positive ALL in the bone marrow, and/or peripheral blood and/or extramedullary sites with the exclusion of Central Nervous System (CNS) if CNS-3 disease.
Exclusion Criteria:
* GVHD Grades II-IV for patients who had previously been transplanted; 2. Any cell therapy in the previous 30 days;
* Patient with concomitant life-threatening infectious disease;
* Lansky/Karnofsky score \<60;
* Patients with hepatic or renal disease as specific above;
* Pregnant or breast-feeding females;
* Rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
75 Years
Study:
NCT05252403
Study Brief:
Protocol Section:
NCT05252403