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.

Study Overview

• Status: Not yet recruiting
• Conditions: Participants Treated With Senza5
• Intervention / Treatment: Biological: Senza5 CART5

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants treated with Senza5 CART5 who have met all eligibility criteria and provided written informed consent for LTFU-Viper 101 (or have written informed consent from their parent[s]/legal guardian[s] and have provided assent, as applicable).

Description

Inclusion Criteria: Participants meeting the following criteria are eligible for trial participation:

1. 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 2. Treated with Senza5 CART5 in a Vittoria BioTherapeutics sponsored clinical trial 3. Able to comply with trial requirements

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Exclusion Criteria:

• There are no exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All drug product-related AEs	15 years

Collaborators and Investigators

• Sponsor: Vittoria Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2041
• Study Completion (Estimated): July 1, 2041

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Viper 101 LTFU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No