Phase 1 Study of CD30 CAR T Cell Therapy for Relapsed or Refractory CD30 Positive Hodgkins and Non-Hodgkin Lymphoma in Patients Aged 12 to 75

What this Trial Is About

This trial studies patients with types of lymph gland cancer called Hodgkins Lymphoma and Non-Hodgkin Lymphoma that have returned or not responded to previous treatments. Researchers are exploring a new approach combining genetically modified T cells with antibodies to better target and kill lymphoma cells. These special T cells, called CD30.CAR T cells, are designed to recognize and attack cancer cells that have a marker named CD30 on their surface. This Phase 1 study aims to test the safety of these modified cells given after chemotherapy that reduces other T cells, creating space for the new cells to work. To make the CD30.CAR T cells, blood is collected from the participant either by blood draw or apheresis if counts are low. The T cells are activated and genetically modified to carry a gene that makes an anti-CD30 antibody attached to the T cell, enhancing their ability to target lymphoma. Participants will receive one injection of these cells on Day 0 after a chemotherapy pre-treatment called lymphodepletion. Depending on response and safety, additional doses of up to six injections may be given at 8 to 12 week intervals. The dose will start low and increase through three levels to find the safest effective amount. During the study, participants will have blood samples taken before and after the T cell infusion at multiple time points up to 15 years. This helps researchers understand how the modified cells behave and last in the body. Participants will be monitored in clinic for at least 3 hours after each infusion for safety. The main outcome is to evaluate dose-limiting side effects within 6 weeks. Other outcomes include measuring response to treatment and the persistence of modified T cells over time. The total duration of involvement can be up to 15 years for long-term follow-up.

CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30)