Phase
Condition
Non-hodgkin's Lymphoma
Lymphoproliferative Disorders
Leukemia
Treatment
N/AClinical Study ID
Ages 16-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphomarelapsing after autologous stem-cell transplantation (ASCT), or refractory to 2multidrug regimens and/or anti-CD30 antibody treatment.
Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who areunable 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% ofexpected corrected for hemoglobin.
Available autologous T cells with 10% or more expression of CD30 CAR determined byflow-cytometry.
Patients or legal guardians must sign an informed consent indicating that they areaware this is a research study and have been told of its possible benefits and toxicside effects. Patients or their guardians will be given a copy of the consent form.
Exclusion
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.
Study Design
Study Description
Connect with a study center
Chinese PLA General Hospital
Beijing, Beijing 100853
ChinaActive - Recruiting
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