Phase 1 Study Evaluating Banked Allogeneic C7R-Modified CD30.CAR EBV-Specific T Cells for Relapsed or Refractory CD30-Positive Lymphomas

What this Trial Is About

Researchers are evaluating a new treatment for patients with relapsed or refractory CD30-positive lymphomas, including diffuse large B cell lymphoma, natural killerT-cell lymphoma, and classical Hodgkin lymphoma. This Phase 1 study focuses on testing C7R-modified CD30.CAR EBV-specific T cells derived from healthy donors, which are engineered to potentially improve anti-cancer activity. The study aims to evaluate the safety and effectiveness of these allogeneic, banked T cells in treating lymphoma. Participants receive one of four escalating dose levels of the investigational C7R.CD30.CAR-EBVST cells administered as a single intravenous infusion. Before treatment, patients undergo evaluations including laboratory tests, imaging, CD30 tumor confirmation, and HLA matching to select the appropriate cell product. Some may receive lymphodepleting chemotherapy to support the infused cells. Those who respond may be eligible for up to three additional infusions at the treating teams discretion. During the study, participants are closely monitored for safety and treatment effects through physical exams, lab tests, imaging, and blood sampling to measure the persistence of infused cells. Follow-up visits occur frequently after infusion, then less often during long-term monitoring for up to 15 years. The primary outcome is dose limiting toxicity within 28 days, with additional outcomes assessing tumor response and disease progression over time.

Constitutive IL7R (C7R) Modified Banked Allogeneic CD30.CAR EBVSTS for CD30-Positive Lymphomas