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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT04747093
Eligibility Criteria:
Inclusion Criteria:
* Patient with CD19 positive B-cell acute leukemia
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* ALT/ AST \<3 x normal
* Bilirubin \< 2.0 mg/dl
* Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
* LVEF\< 45%
* Accept white blood cell collection
* Provide informed consent
Exclusion Criteria:
* Previous treatment with investigational gene or cell therapy medicine products
* Active hepatitis B , hepatitis C or HIV infection
* Uncontrolled active infection
* Presence of grade 2-4 acute or extensive chronic GVHD
* Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
* Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Received non-diagnostic purposes major surgery within the past 4 weeks
* Participated in any other clinical study within the past 4 weeks
* Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
* Pregnancy or breast-feeding women
* Use of prohibited drugs:
* Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to ITNK Cells infusion
* Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to ITNK Cells infusion
* GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to ITNK Cells infusion
* Any situation that may increase the risk of the test or interfere with the test results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04747093
Study Brief:
Protocol Section:
NCT04747093