CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Study Overview
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Brief Summary
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Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Detailed Description
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When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days. Extra blood will be drawn to measure the persistence of CART30 in vivo.

Official Title
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CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Conditions
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Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Biological: CART30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment. Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy. Karnofsky or Lansky score greater than 60%. Expected survival>12 weeks. Creatinine<2.5mg/dl. ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal. Bilirubin<2.5mg/dl. Pulse oximetry of >90% on room air. Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin. Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry. Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. Exclusion Criteria: Active infection such as hepatitis B or C. Receive anti-CD30 antibody-based therapy within recent 6 weeks. Current use of systemic corticosteroids. Pregnant or lactating. Confirmed tumor in pulmonary and archenteric tissues.

Ages Eligible for Study
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Minimum Age: 16 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: anti-CD30 CAR T cells<br>Patients receive CART30 cell infusions with an escalation dose. | Biological: CART30<br>* Cells will be infused 1 day after the completion of conditioning regimen.<br>* Other names: anti-CD30 CAR T cells;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of related adverse events |  | untill week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor response to CART30 cell infusions | Evaluated mainly by computed tomography scanning | Up to 24 weeks |