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

Verismo Therapeutics

Status

Invitation-only

Conditions

Cancer

Treatments

Drug: SynKIR-310

Drug: SynKIR-110

Study type

Observational

Funder types

Industry

Identifiers

NCT06701201

LTFU 101-00

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.