Gene Therapy Using Anti-CCR4 CAR T Cells for Adults with Relapsed or Resistant Mature T-Cell Lymphomas Expressing CCR4 A Phase 1 Dose Escalation Trial

What this Trial Is About

Researchers are studying a gene therapy treatment for adults with certain mature T-cell lymphomas that express the CCR4 protein. This trial focuses on patients whose lymphoma has returned or not responded to previous treatments. The main goal is to evaluate the safety of modifying a persons own white blood cells to attack these cancer cells using a specific receptor called anti-CCR4 CAR. This study is a phase 1, open-label, non-randomized trial conducted by the National Cancer Institute. Participants will first undergo screening, including medical history, physical exams, and several tests such as blood, urine, heart, and lung function tests. Imaging scans like CT, PET, and MRI will be performed to assess the disease. Tumor biopsies and bone marrow samples may also be collected. Participants undergo leukapheresis to collect T-cells, which are then genetically modified to target CCR4 on cancer cells. Before receiving the modified cells, patients will get chemotherapy drugs intravenously to prepare their body. The modified cells are infused through an IV over 10 to 30 minutes. Dose levels will be escalated to find the maximum tolerated dose. After treatment, participants will be followed for up to 15 years with regular blood tests during the first 1 to 2 years and yearly visits or telehealth updates. Researchers will monitor safety, treatment effects, and long-term outcomes, including survival and response rates. Assessments include periodic imaging and lab tests to evaluate the persistence of the modified cells and the participants response to the therapy.

A Phase I Trial Anti-CC Chemokine Receptor 4 Chimeric Antigen Receptor T Cells (CCR4 CAR T Cells) for CCR4 Expressing T-cell Malignancies Including Peripheral T-cell Non-Hodgkin Lymphoma (PTCL) and Cutaneous T-cell Non-Hodgkin Lymphoma (CTCL)