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CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Recruiting
2 - 80 years of age
Both
Phase 1

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Overview

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.

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;

Study details

Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma

NCT03383965

Immune Cell, Inc.

27 January 2024

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