Phase 2 Study of T Cells Engineered to Target CD30 for Adults with Relapsed or Refractory CD30 Peripheral T Cell Lymphoma

What this Trial Is About

Researchers are studying the safety and tolerability of ATLCAR.CD30, a treatment using genetically modified T cells that target the CD30 antigen found on lymphoma cancer cells, in people with relapsed or refractory Peripheral T Cell Lymphoma. This phase II open-label trial involves participants whose T cells are collected and modified to produce a CD30 antibody, aiming to help the immune system attack the cancer. The study is sponsored by UNC Lineberger Comprehensive Cancer Center and includes patients who have undergone previous treatments. Participants receive two infusions of ATLCAR.CD30 cells, each preceded by lymphodepleting chemotherapy. The first lymphodepletion uses bendamustine and fludarabine, while the second uses cyclophosphamide and fludarabine, given 2 to 14 days before each infusion. If participants cannot tolerate bendamustine, an alternative regimen with cyclophosphamide and fludarabine is used before the first infusion. The ATLCAR.CD30 cells are infused intravenously over 5 to 10 minutes, with the volume depending on cell concentration and participant size. Participants may receive bridging standard-of-care therapy while their cells are being prepared. During the study, participants undergo blood sampling, imaging scans CT or PETCT, and various laboratory tests to monitor disease status and organ function. They will be followed for up to 15 years after treatment to assess long-term outcomes, including progression-free survival and overall survival. Safety is closely monitored, including potential side effects like infection, fever, neurotoxicity, and cytokine release syndrome. Clinic visits generally last between 1 to 8 hours, and participants may receive a second infusion if they show clinical benefit and meet eligibility for the second treatment phase.

CD30 CAR for Relapsed/Refractory CD30+ T Cell Lymphoma