CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Study of CD30 Targeted CAR-T in Treating CD30-Expressing Lymphomas

Conditions
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Hodgkin Lymphoma, Anaplastic Large Cell Lymphoma

Intervention / Treatment
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* Biological: ICAR30 T cells


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICAR30 T cells<br>anti-CD30 CAR-T cells. Patients receive ICAR30 T cells infusion. | Biological: ICAR30 T cells<br>* T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.<br>* Other names: Biological drug;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |