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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-27

Study Completion Date

2042-02-28

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SynKIR-110

Participants who previously received SynKIR-110 in an interventional trial

SynKIR-110

Intervention Type DRUG

Autologous T cells Transduced with Mesothelin KIR-CAR

SynKIR-310

Participants who previously received SynKIR-310 in an interventional trial

SynKIR-310

Intervention Type DRUG

Autologous T Cells transduced with CD19 KIR-CAR

Interventions

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SynKIR-110

Autologous T cells Transduced with Mesothelin KIR-CAR

Intervention Type DRUG

SynKIR-310

Autologous T Cells transduced with CD19 KIR-CAR

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No