Study of Allogeneic KCAT19 T Cells for Treating Advanced CD19 Blood Cancers Phase 1 Trial in Adults Aged 16 to 65 Years

What this Trial Is About

Researchers are studying KCAT19, a type of advanced therapy investigational medicinal product ATIMP, in adults aged 16 to 65 years with high-risk, relapsed or refractory B cell malignancies such as B-ALL, LBCL, MCL, and indolent B-NHL. This Phase I clinical trial aims to confirm that KCAT19 T cells can be produced in the lab, assess their safety, and gather initial information about their activity against these cancers. The study involves manufacturing allogeneic KCAT19 T cells from HLA-matched cord blood donors. After informed consent and registration, donor T cells are genetically modified in the lab to target CD19 on malignant B cells. During the 15-day manufacturing process, patients may receive holding chemotherapy or immunotherapy. Before infusion, patients undergo pre-conditioning with cyclophosphamide and fludarabine. The KCAT19 T cells are then infused intravenously on day 0. Participants are closely monitored in the hospital for at least 14 days post-infusion with regular blood tests and observations to detect potential side effects. Disease assessments occur at baseline, 1 month, 6 months, and 12 months after infusion. After discharge, patients have monthly follow-up visits for 6 months, then visits every 6 weeks until 12 months, quarterly visits for another year, and annual visits until the trial ends, up to 10 years in total.

Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies