Status:
UNKNOWN
Induced-T Cell Like NK Cells for B Cell Malignancies
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
B Cell Leukemia
B Cell Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Relapsed and refractory B cell malignancies show unfavorable prognosis, especially for adult patients. Now, there is no standard management for these patients. Induced-T cell-like NK cells with chimer...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04747093
Start Date
January 29 2021
End Date
March 31 2022
Last Update
February 10 2021
Active Locations (1)
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1
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515