CD30-targeted CAR T-cell therapy for relapsed and refractory lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the use of CD30-directed chimeric antigen receptor T (CART30) therapy for patients with relapsed or refractory Hodgkin's lymphoma and Non-Hodgkin's lymphoma. Patients will undergo a conditioning regimen with cyclophosphamide and fludarabine before receiving infusions of their own modified T cells that target CD30. The trial aims to assess the safety and efficacy of this innovative treatment approach, with additional monitoring of the persistence of CART30 cells in the body.

Why it matters

Who can join: the full rules

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.

Where it's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Weidong Han, Ph.D
• Email: hanwdrsw@sina.com
• Phone: 86-10-66937463

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.