Phase I Trial of CLIC-2201 CAR-T Cell Therapy for Relapsed or Refractory B Cell Leukemia and Lymphoma

What this Trial Is About

Researchers are evaluating CLIC-2201, an autologous CD22-targeting CAR-T cell therapy, in a phase I trial for people with relapsed or refractory B cell malignancies. The study aims to determine the safety, tolerability, and maximum tolerated dose of CLIC-2201, while also assessing its feasibility, anti-tumor activity, pharmacokinetics, immune responses, biomarkers, and quality of life over up to 15 years. The trial includes adult and pediatricyoung adult participants with various aggressive B cell cancers. Participants will undergo leukapheresis to collect their own T cells, which are then modified and expanded in a lab to create CLIC-2201. Before receiving the infusion, they will have lymphodepleting chemotherapy with cyclophosphamide and fludarabine to help the CAR-T cells work effectively. The CLIC-2201 is infused intravenously. The dose will be adjusted using a 33 design to identify the best tolerated dose, with adults treated first at each level before pediatric participants. Participants will stay in the hospital for at least 7 days after infusion for close monitoring. During the study, participants will have scheduled visits for up to two years and annual follow-ups up to 15 years to assess safety, side effects, response to treatment, immune profiles, and quality of life. Researchers will monitor various safety outcomes including cytokine release syndrome and neurological events. The trial involves tests like biopsies, blood samples, and clinical assessments to track the effects of the therapy and participant health throughout the study.

CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies