Phase I Trial of Anti-CCR4 CAR T Cells for CCR4-Expressing Mature T-cell Malignancies Including Peripheral and Cutaneous T-cell Lymphomas

What this Trial Is About

Researchers are evaluating a gene therapy treatment for adults with certain mature T-cell lymphomas that express the CCR4 protein and have not responded to or have relapsed after previous treatments. This phase I trial aims to test the safety of giving participants their own white blood cells, modified to attack the CCR4 protein on their cancer cells. The study focuses on various T-cell lymphoma subtypes, including peripheral T-cell lymphoma and cutaneous T-cell lymphoma, among others. Participants will first undergo leukapheresis, a procedure to collect their T-cells, which will then be genetically modified to express anti-CCR4 chimeric antigen receptors CARs. Before receiving the modified cells, participants will have conditioning chemotherapy with cyclophosphamide and fludarabine over three days. The modified CAR T cells will then be infused intravenously. The study includes dose escalation to find the maximum tolerated dose, with groups receiving varying doses, followed by an expansion cohort at the identified dose level. Throughout the trial, participants will undergo extensive monitoring including CT, PET, and MRI scans, biopsies, blood and urine tests, and heart and lung function assessments. Leukapheresis and cell infusions will be carefully timed, and participants will be followed for up to 15 years to assess long-term safety and treatment effects. Visits will include blood tests frequently during the first two years and yearly follow-ups thereafter, with some visits possibly conducted via telehealth.

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)