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

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.

Inclusion criteria

Participants meeting the following criteria are eligible for trial participation:

• Provision of written informed consent by the participant or provision of written informed consent from the participant's parent[s]/legal guardian[s] and provision of assent from the participant, as applicable
• Treated with Senza5 CART5 in a Vittoria BioTherapeutics sponsored clinical trial
• Able to comply with trial requirements

Exclusion criteria

• There are no exclusion criteria.