Last updated: February 6, 2021
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting
Phase
1/2
Condition
Leukemia
Chronic Lymphocytic Leukemia
Lymphoma
Treatment
N/AClinical Study ID
NCT04747093
ITNK-2021
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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 asoutlined.
- 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 noanti-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 Cellsinfusion
- 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 Cellsinfusion
- Any situation that may increase the risk of the test or interfere with the testresults
Study Design
Total Participants: 12
Study Start date:
January 29, 2021
Estimated Completion Date:
March 31, 2022
Connect with a study center
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
ChinaActive - Recruiting

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