Status:
RECRUITING
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
16-80 years
Phase:
PHASE1
PHASE2
Brief Summary
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-specif...
Detailed Description
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 CAR...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02259556
Start Date
October 1 2014
End Date
October 1 2029
Last Update
January 28 2016
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853