An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders

This is a Phase I/II open-label, non-interventional, single-arm follow-up study evaluating the long-term safety and efficacy of anti-CD19 CAR-T cell therapy in adult patients with relapsed or refractory B-cell lymphoproliferative disorders. CAR-T cell therapy is an advanced immunotherapy that modifies a patient's T cells to target the CD19 antigen on B cells. This follow-up study focuses on assessing the durability of treatment responses and monitoring potential late-onset adverse events in patients who previously received anti-CD19 CAR-T cells during the HemC101-01-01 trial (NCT06705530). The primary objective of this study is to evaluate the long-term safety profile of second-generation anti-CD19 CAR-T cells, including the incidence, duration, and severity of adverse events. Secondary objectives include assessing the durability of clinical responses, such as overall response rate (ORR), progression-free survival (PFS), duration of response (DoR), and overall survival (OS). Additionally, the study aims to monitor the persistence and expansion of CAR-T cells in peripheral blood and detect the development of anti-drug antibodies (ADAs) that may impact therapeutic efficacy. Eligible participants include adults aged 18-70 who completed the HemC101-01-01 trial and meet all inclusion criteria, such as sufficient organ function and negative pregnancy tests where applicable. This study involves periodic follow-up visits over 11 months post-CAR-T cell infusion, during which clinical assessments, laboratory evaluations, and safety monitoring will be conducted. No additional CAR-T cell infusions will be administered in this follow-up study. The trial is conducted at a single clinical center in Russia under the sponsorship of the National Medical Research Center of Hematology, Ministry of Health of Russia. The data collected will provide insights into the long-term safety and efficacy of anti-CD19 CAR-T therapy, contributing to the development of treatment protocols and improving outcomes for patients with relapsed or refractory B-cell malignancies.