A Phase I Multicenter Study of Autologous CD19 CAR T-Cell Therapy in Patients with Refractory Chronic Graft-versus-Host Disease

The primary objective of this phase I study is to evaluate the safety and efficacy of autologous CD19 CAR T cells in patients with refractory chronic Graft-versus-Host Disease. This investigation is clinically relevant for addressing therapeutic options in cases where standard treatments have failed to manage the systemic complications of the disease. No secondary objectives were reported.

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with chronic Graft-versus-Host Disease. The cohort includes both male and female individuals. Based on the provided age range codes, the participants belong to specific pediatric or young adult age groups. The population is classified as vulnerable.

This is a multicenter, Phase I clinical study evaluating the efficacy and safety of autologous CD19 CAR T cells in patients with refractory chronic Graft-versus-Host Disease. The study design involves a systematic progression of clinical assessments. An initial screening visit is conducted to determine eligibility based on predefined criteria. Following successful enrollment, participants undergo the therapeutic intervention and subsequent follow-up visits to monitor clinical responses and potential adverse events. The process concludes with an end-of-study visit. The total duration of participant involvement is determined by the protocol-specified observation period. Early termination from the study may occur if specific clinical conditions or safety criteria are met.

The assessment of efficacy in this Phase 3 clinical trial focuses on the management of chronic Graft-versus-Host Disease. Specific parameters and methodologies for evaluating therapeutic response are not specified in the provided documentation.