Clinical Trial

CD5-deleted Chimeric Antigen Receptor Cells (Senza5 CART5) for T Cell Non-Hodgkin Lymphoma (NHL)

Study acronym: VIPER101
Recruiting Phase 1
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Summary
This is an open-label phase I study to determine the safety and recommended phase 2 dose (RP2D) of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL. RP2D will be based on the safety, tolerability, pharmacokinetics, and preliminary efficacy of Senza5 CART5 cells. This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval (BOIN) design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-05-16; most recent amendment 2025-11-05.
Status change: Not Yet Recruiting → Recruiting 2024-07-25
Trial Details
NCT Number NCT06420089
Lead Sponsor Vittoria Biotherapeutics
Collaborators: University of Pennsylvania
Conditions T Cell Non-Hodgkin Lymphoma
Enrollment 30 participants
Start Date 2024-10-04
Primary Completion 2028-08-30 (estimated)
Study Completion 2029-08-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-10