CAR T-cell therapy for relapsed or resistant CD30-positive lymphoma
Tests CD30-targeted CAR T cells in people with CD30-positive Hodgkin or non-Hodgkin lymphoma.
Plain-language title generated from the registry record
Registry title: CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 80 years old?
Source: NCT02259556, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese PLA General Hospital
- Trial code
- NCT02259556
- Record updated
- 28 January 2016
- Original description
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).Read full original descriptionShow less
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).
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: Receive anti-CD30 antibody-based therapy within recent 6 weeks; Current use of systemic corticosteroids; Active infection such as hepatitis B or C; Pregnant or lactating; Confirmed tumor in pulmonary and archenteric tissues.