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

NCT07683897 | Not Yet Recruiting FDA Drug

• 1 other identifier: Viper 101 LTFU
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Participants Treated With Senza5

Outcome Measures

Primary Outcomes (1)

• All drug product-related AEs

  15 years

Interventions

Senza5 CART5 BIOLOGICAL

Senza5 CART5

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

Sponsors & Collaborators

• Vittoria Biotherapeutics: lead

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2041
• Study Completion (Estimated): July 1, 2041
• Last Updated: July 30, 2026

Record last verified: 2026-07