Ireland
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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
Phase
Phase 1/2
Started
2014-10
Last updated
2016-01-28

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

Sex
ALL
Min age
16 Years
Max age
80 Years
Healthy volunteers
No
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)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting
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