CD30-targeted CAR T-cell therapy for relapsed and refractory lymphomas
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
This study is testing a new treatment using modified T cells to see if it can help people with relapsed or hard-to-treat Hodgkin's and Non-Hodgkin's lymphoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese PLA General Hospital Academic / other |
| Drugs / interventions | chemotherapy, CART, Chimeric antigen receptor, cyclophosphamide, fludarabine |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT02259556 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with CD30 positive Hodgkin's lymphoma or Non-Hodgkin's lymphoma who have relapsed after autologous stem-cell transplantation or are refractory to standard treatments.
Not a fit: Patients with CD30 negative lymphomas or those who are not eligible for the specified inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat lymphomas.
How similar studies have performed: Other studies utilizing CAR T-cell therapy have shown promising results, indicating potential for success with this specific approach targeting CD30.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.