Status:
UNKNOWN
A Clinical Study of CD19 Targeted CAR-T for Patients With CD19+ Lymphoma and Leukemia
Lead Sponsor:
Immune Cell, Inc.
Collaborating Sponsors:
Weifang People's Hospital
Conditions:
B Cell Leukemia
B Cell Lymphoma
Eligibility:
All Genders
2-80 years
Phase:
PHASE1
Brief Summary
Immunotherapy offers an extremely precise approach with the potential to eliminate cancer cells specifically. The newly designed CD19 targeted ICAR19 T cells can specifically kill CD19+ tumor cells. I...
Eligibility Criteria
Inclusion
- CD19 positive leukemia and lymphoma，relapsed and/or refractory：
- survival\>12 weeks;
- FEV1, FVC and DLCO ≥50% of expected corrected for hemoglobin;
- LVEF≥50%;
- Creatinine\<2.5mg/dl;
- Bilirubin\<2.5mg/dl;
- ALT (alanine aminotransferase)/AST (aspartate aminotransferase)\<3 x normal;
- At least 7 days after last chemotherapy;
- provide with informed consent.
Exclusion
- Active clinically significant CNS dysfunction
- Pregnant or breast-feeding women.
- Uncontrolled active infection including hepatitis B or C.
- HIV positive.
- Use of systemic steroids within 72 hours.
- Allogeneic lymphocyte treatments within recent 6 months.
- Any uncontrolled active medical disorder.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03383952
Start Date
March 1 2017
End Date
December 31 2025
Last Update
December 27 2017
Active Locations (1)
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1
Weifang People's Hospital
Weifang, Shandong, China, 261000