Non-Hodgkin's Lymphoma Clinical Trial
— CART30Official title:
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 2029 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 80 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Chinese PLA General Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese PLA General Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | in vivo existence of CART30 | Measure mainly by the changes of CAR molecule levels in blood | 1 year | Yes |
Primary | Occurrence of related adverse events | untill week 24 | Yes | |
Secondary | Anti-tumor response to CART30 cell infusions | Evaluated mainly by computed tomography scanning | Up to 24 weeks | No |
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