Clinical trial NCT06701201: A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
Official title: A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cancer
Keywords: Cancer
CAR-T
CAR-T Cells
KIR-CAR
Lead sponsor: Verismo Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 exclusion criteria.

Primary outcomes:
measure: To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
timeFrame: Up to 15 years from SynKIR CAR T cell product administration
measure: To monitor the long-term safety of participants that have been infused with a SynKIR CAR cell product
timeFrame: Up to 15 years from SynKIR CAR T cell product administration
Secondary outcomes:
measure: To assess the long-term clinical efficacy of SynKIR CAR T cell product
timeFrame: Up to 15 years from SynKIR CAR T cell product administration
measure: To assess the long-term clinical efficacy of SynKIR CAR T cell product
timeFrame: Up to 15 years from SynKIR CAR T cell product administration
measure: To assess the persistence of SynKIR-modified T cells
timeFrame: Up to 15 years from SynKIR CAR T cell product administration
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Philadelphia
country: United States
facility: University of Pennsylvania Abramson Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
References: