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

August 3, 2026 updated by: Verismo Therapeutics
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Cancer Institute
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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
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
Time Frame: Up to 15 years from SynKIR CAR T cell product administration
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
Time Frame: Up to 15 years from SynKIR CAR T cell product administration
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
Time Frame: Up to 15 years from SynKIR CAR T cell product administration
Progression-free survival
Up to 15 years from SynKIR CAR T cell product administration
To assess the persistence of SynKIR-modified T cells
Time Frame: Up to 15 years from SynKIR CAR T cell product administration
Presence of a SynKIR CAR DNA sequence
Up to 15 years from SynKIR CAR T cell product administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verismo Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

August 4, 2026

Last Update Submitted That Met QC Criteria

August 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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