Avencell AVC-Persist is a multicenter, non-interventional, observational Long-Term Follow-up (LTFU) study evaluating the long-term safety and persistence of adoptively transferred CAR-T cells following AvenCell CAR-T cell therapy in treated oncological patients. The study's primary objective is to assess the incidence of treatment-emergent adverse events (TEAEs) over an extended follow-up period. Enrolled are adult patients with hematologic and lymphatic malignancies from preceding AvenCell CAR-T cell trials who have completed the initial treatment phase. Participants are followed up at predefined intervals for up to 15 years post-initial CAR-T infusion. Key secondary endpoints include pharmacodynamics (CAR-T cell persistence), Overall Survival (OS), disease status, and the occurrence of secondary malignancies.
This observational study, named Avencell AVC-Persist, is a long-term follow-up trial involving people who previously received a special immunotherapy (CAR-T cell therapy) from AvenCell. The aim is to monitor the long-term safety of this cell therapy and to determine how long the therapeutic cells persist in the body. Adult patients from previous AvenCell trials who successfully completed their treatment are enrolled. Participants will undergo regular check-ups over the years to evaluate the safety and efficacy of the CAR-T cells over an extended period. Important secondary objectives include monitoring disease status and quality of life after treatment.
