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

• Conditions: Cancer
• Interventions: Drug: SynKIR-310; Drug: SynKIR-110

• Registration Number: NCT06701201
• Lead Sponsor: Verismo Therapeutics

Brief 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.

Study Timeline

• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Study Start: 2025-01-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-07
• Primary Completion: 2042-02
• Study Completion: 2042-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

1. All adult participants who have received any amount of SynKIR CAR T cell product in a study sponsored by Verismo Therapeutics.
2. Participant is willing and able to comply with the study requirements.

Exclusion Criteria

There are no specific exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SynKIR-310	SynKIR-310	Participants who previously received SynKIR-310 in an interventional trial
SynKIR-110	SynKIR-110	Participants who previously received SynKIR-110 in an interventional trial

Primary Outcome Measures

Name	Time	Method
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product	Up to 15 years from SynKIR CAR T cell product administration	Frequency and severity of delayed AEs considered related to SynKIR CAR T cell product
To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product	Up to 15 years from SynKIR CAR T cell product administration	Presence of RCL VSV-G DNA

Secondary Outcome Measures

Name	Time	Method
To assess the long-term clinical efficacy of SynKIR CAR T cell product	Up to 15 years from SynKIR CAR T cell product administration	Progression-free survival
To assess the persistence of SynKIR-modified T cells	Up to 15 years from SynKIR CAR T cell product administration	Presence of a SynKIR CAR DNA sequence

Trial Locations

Locations (4)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

University of Pennsylvania Abramson Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States