NCT02259556 CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
| NCT ID | NCT02259556 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Chinese PLA General Hospital |
| Condition | Hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2014-10 |
| Primary Completion | 2018-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2014-10 with a primary completion date of 2018-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Weidong Han, Ph.D
STUDY CHAIR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT02259556 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 80 Years, studying Hodgkin's Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02259556 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02259556 currently recruiting?
Yes, NCT02259556 is actively recruiting participants. Contact the research team at hanwdrsw@sina.com for enrollment information.
Where is the NCT02259556 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT02259556 clinical trial?
NCT02259556 is sponsored by Chinese PLA General Hospital. The principal investigator is Weidong Han, Ph.D at Chinese PLA General Hospital. The trial plans to enroll 30 participants.