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Recruiting Phase 1 / Phase 2

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

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About this study

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).

Condition
Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
Tested
CART30
Sponsor
Chinese PLA General Hospital

Who can join

Age
16 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 16 years
  • Maximum age: 80 years
  • Study condition: Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
  • 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 5

  • 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.

Where

1 site, 1 recruiting

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.