Clinical Trials in China / NCT02259556
Recruiting
Phase 1/2
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
NCT02259556 · tracked via the Priya Life Science China tracker
Condition(s) studied
Hodgkin's LymphomaNon-Hodgkin's Lymphoma
Investigational drug(s) / intervention(s)
CART30
CART30: Cells will be infused 1 day after the completion of conditioning regimen.
Study 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-specific CART cells (CART30).
Eligibility
Inclusion Criteria:
* 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 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.
Primary outcome measure(s)
- Occurrence of related adverse events — untill week 24
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02259556 on ClinicalTrials.gov ↗ ← All trials in China