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Enrolling by Invitation

NCT Number: NCT06701201

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Exclusion criteria

There are no specific exclusion criteria.

Treatment and study plan

SynKIR-110

Drug

Autologous T cells Transduced with Mesothelin KIR-CAR

SynKIR-310

Drug

Autologous T Cells transduced with CD19 KIR-CAR

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Verismo Therapeutics

Industry

Registry information

Important dates

Study start
2025
Primary completion
2042
Study completion
2042
First posted
Nov 22, 2024
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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