NCT02259556RecruitingPhase 1/2
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Source: ClinicalTrials.gov · Last updated 28 Jan 2016 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 5 Oct 2014
- Start date
- 1 Oct 2014
- Primary completion date
- 31 Oct 2018
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Hodgkin lymphoma, Childhood cancers
- NCT number
- NCT02259556
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 30
- From 1 Oct 2014 to the primary completion date, 31 Oct 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receive anti-CD30 antibody-based therapy within recent 6 weeks.
- Current use of systemic corticosteroids.
Other illness
- Active infection such as hepatitis B or C.
Other
- Pregnant or lactating.
- Confirmed tumor in pulmonary and archenteric tissues.
Who the study is looking for
- 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.
Age in the registry: 16 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.