Phase 1 Study of Tarcidomgen Kimleucel CAR T Cells for Treating Adults 18-65 with Relapsed or Refractory CD19 B Cell Cancers

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of a new investigational medicinal product called FCTX-CL19-1 Tarcidomgen Kimleucel, which contains autologous anti-CD19 CAR T cells. This phase I open-label study focuses on patients with relapsed or refractory CD19-positive B cell cancers, including acute lymphoblastic leukemia, mantle cell lymphoma, and large B-cell lymphoma. The study aims to see if this gene therapy approach is safe and can induce remission in these treatment-resistant cancers. The treatment involves a single intravenous dose of FCTX-CL19-1 administered by investigators during hospitalization. The dose ranges from 0.2 to 2 million CAR T cells per kilogram of the patients body weight. This therapy uses the patients own modified T cells engineered to target CD19 on malignant B cells. The study carefully monitors the safety of this administration and evaluates responses in terms of remission and treatment failures. Participants will be closely observed throughout the study, which lasts about one year on average. Researchers will assess side effects such as cytokine release syndrome and neurological events, as well as infections, cytopenia, and other adverse events. They will also monitor the participants response to therapy, including complete or partial remission rates. Patients undergo regular clinical evaluations, lab tests, and organ function assessments to ensure safety and to measure outcomes during the study period.

CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms