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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Cancer
• Intervention / Treatment: Drug: SynKIR-110; Drug: SynKIR-310

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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Abramson Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • Md Anderson Cancer Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants must have received at least 1 infusion of a SynKIR CAR T cell product in a Verismo Therapeutics parent protocol.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SynKIR-110; Participants who previously received SynKIR-110 in an interventional trial	Drug: SynKIR-110; Autologous T cells Transduced with Mesothelin KIR-CAR
SynKIR-310; Participants who previously received SynKIR-310 in an interventional trial	Drug: SynKIR-310; Autologous T Cells transduced with CD19 KIR-CAR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Verismo Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2025
• Primary Completion (Estimated): February 1, 2042
• Study Completion (Estimated): February 1, 2042

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cancer; CAR-T; CAR-T Cells; KIR-CAR
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LTFU 101-00

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No