Hodgkin Lymphoma Clinical Trial
Official title:
A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas
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 newly CD30 targeted CART therapy ICAR30 is designed to specifically kill those CD30 expressing malignancies including Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. The subjects will receive several doses of autologous ICAR30 T cells infusion and then the safety, treating effects and lasting period of these cells in vivo will be evaluated.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 80 Years |
Eligibility |
Inclusion Criteria: 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 Criteria: - 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; |
Country | Name | City | State |
---|---|---|---|
China | Weifang People's Hospital | Weifang | Shandong |
Lead Sponsor | Collaborator |
---|---|
Immune Cell, Inc. | Weifang People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure the safety of ICAR30 T cells | To assess the adverse events of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. | 2 years | |
Secondary | Measure the anti-tumor effect of ICAR30 T cells | To assess the anti-tumor effect of ICAR30 T cells infusion in patients with Hodgkin's lymphoma and CD30+ anaplastic large cell lymphoma. | 3 years | |
Secondary | Measure the survival time of ICAR30 T cells in vivo | To measure the survival time of ICAR30 T cells in vivo, extra blood will be drawn from patients receive ICAR30 T cells infusion in the follow-up time. | 5 years |
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