Status:
UNKNOWN
CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
Lead Sponsor:
Immune Cell, Inc.
Collaborating Sponsors:
Weifang People's Hospital
Conditions:
Hodgkin Lymphoma
Anaplastic Large Cell Lymphoma
Eligibility:
All Genders
2-80 years
Phase:
PHASE1
Brief Summary
CAR-T cells have been validated effective in treating CD19 positive B cell lymphoma. Other lymphomas like Hodgkin's lymphoma and anaplastic large cell lymphoma are CD30 positive. In this study, a newl...
Eligibility Criteria
Inclusion
- Hodgkin's lymphoma, anaplastic large cell lymphoma and other CD30 positive malignancies, relapsed or refractory:
- Karnofsky or Lansky score \>50;
- Expected survival\>12 weeks;
- Hgb \> 8.0;
- 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 fold normal;
- Patients must sign an informed consent.
Exclusion
- Pregnant or lactating;
- Uncontrolled active infection including hepatitis B or C;
- HIV positive;
- Active clinically significant CNS dysfunction;
- Current use of systemic steroids;
- Heterogenous lymphocyte treatments within recent 6 months;
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
NCT03383965
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