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Enrolling by invitationNCT06701201Updated Aug 4, 2026

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

An observational study in Cancer, sponsored by Verismo Therapeutics. Enrolling by invitation at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.

Sponsored by Verismo Therapeutics · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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.

02

Conditions studied

  • Cancer

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Keywords

  • Cancer
  • CAR-T
  • CAR-T Cells
  • KIR-CAR
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 60 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Verismo Therapeutics is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

There are no specific exclusion criteria.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • SynKIR-110

    Participants who previously received SynKIR-110 in an interventional trial

    Drug: SynKIR-110

  • SynKIR-310

    Participants who previously received SynKIR-310 in an interventional trial

    Drug: SynKIR-310

Interventions

  • DrugSynKIR-110

    Autologous T cells Transduced with Mesothelin KIR-CAR

  • DrugSynKIR-310

    Autologous T Cells transduced with CD19 KIR-CAR

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 15 years from SynKIR CAR T cell product administration

  2. To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product

    Presence of RCL VSV-G DNA

    Time frame: Up to 15 years from SynKIR CAR T cell product administration

Secondary outcomes

  1. To assess the long-term clinical efficacy of SynKIR CAR T cell product

    Overall survival

    Time frame: Up to 15 years from SynKIR CAR T cell product administration

  2. To assess the long-term clinical efficacy of SynKIR CAR T cell product

    Progression-free survival

    Time frame: Up to 15 years from SynKIR CAR T cell product administration

  3. To assess the persistence of SynKIR-modified T cells

    Presence of a SynKIR CAR DNA sequence

    Time frame: Up to 15 years from SynKIR CAR T cell product administration

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Study locations

7 sites
  • Colorado Blood Cancer Institute, part of Sarah Cannon Research Institute
    Denver, Colorado 80218, United States
  • Winship Cancer Institute of Emory University
    Atlanta, Georgia 30322, United States
  • University of Kansas Cancer Center
    Westwood, Kansas 66205, United States
  • Rutgers Cancer Institute
    New Brunswick, New Jersey 08901, United States
  • University of Pennsylvania Abramson Cancer Center
    Philadelphia, Pennsylvania 19104, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • University of Wisconsin Carbone Cancer Center
    Madison, Wisconsin 53792, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06701201
Lead sponsor
Verismo Therapeutics
Responsible party
Sponsor
First posted
Nov 22, 2024
Start date
Jan 27, 2025
Primary completion
Feb 2042 (estimated)
Completion
Feb 2042 (estimated)
Last update
Aug 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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