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

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06701201

Enrollment

Registered

2024-11-22

Start date

2025-01-27

Completion date

2042-02-01

Last updated

2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, CAR-T, CAR-T Cells, KIR-CAR

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.

Interventions

DRUGSynKIR-110

Autologous T cells Transduced with Mesothelin KIR-CAR

DRUGSynKIR-310

Autologous T Cells transduced with CD19 KIR-CAR

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
To assess the long-term clinical efficacy of SynKIR CAR T cell product	Up to 15 years from SynKIR CAR T cell product administration	Overall 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026