A Long-Term Follow-Up Trial for Participants Enrolled in CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) Trials

Overview

This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5.

This is an open label, multi-center, long-term safety and efficacy follow-up trial for participants who have been treated with Senza5 CART5. The US Food and Drug Administration (FDA 2018) and European Medicines Agency (EMA 2009) recommend long-term follow-up (LTFU) for participants treated with gene therapy drug products to monitor for selected adverse events (AEs) as well as durability of clinical response (FDA Guidance 2020). Participants enrolled in LTFU-Viper101 will be followed every 6 months through 5 years following Senza5 CART5 infusion, then annually through 15 years. Vector copy number (VCN) will be measured at designated time points during scheduled trial visits. Safety evaluations to be performed during the trial include, but are not limited to, physical examinations; documentation of serious adverse events (SAEs), drug product-related adverse events (AEs), serious or non-serious immune-related AEs (e.g., autoimmune disorders, graft-versus-host disease \[GVHD\], opportunistic infections, human immunodeficiency virus \[HIV\]), new or worsening hematologic or neurologic disorders (as determined by the Investigator), and malignancies; long-term surveillance for evidence of replication competent lentivirus (RCL); and characterization of events of insertional mutagenesis leading to clonal dominance or oncogenesis.

Conditions

Interventions

Eligibility

Outcomes