NCT06701201

A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Verismo Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to monitor potential long-term risks associated with the administration of SynKIR CAR T cell products.

Detailed description

This is a study for the Long Term Follow Up for all participants treated with Verismo Therapeutics' SynKIR CAR T cell products in accordance with regulatory guidance. The primary objective of this study is to monitor the long-term safety of SynKIR CAR T cell products. No investigational product will be administered in this LTFU study. Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product under a Verismo Therapeutics parent protocol. Participants will be invited to enroll into this LTFU study after either early discontinuation from or completion of the parent protocol. In accordance with regulatory guidelines, this study will follow participants for a period of 15 years following infusion of Verismo Therapeutics' SynKIR CAR T cell product, to monitor for delayed adverse events (AEs), detection of replication competent lentivirus (RCL), and to assess long-term efficacy and persistence of gene-modified T cells.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	SynKIR-110	Autologous T cells Transduced with Mesothelin KIR-CAR
DRUG	SynKIR-310	Autologous T Cells transduced with CD19 KIR-CAR

Timeline

• Start date: 2025-01-27
• Primary completion: 2042-02-01
• Completion: 2042-02-01
• First posted: 2024-11-22
• Last updated: 2026-02-10

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study