A Long-Term Follow-Up Basket Study for Participants Treated With SynKIR Chimeric Antigen Receptor (CAR) T Cell Product
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 60
- Locations
- 10
- Primary Endpoint
- To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
SynKIR-310
Participants who previously received SynKIR-310 in an interventional trial
Intervention: SynKIR-310 (Drug)
SynKIR-110
Participants who previously received SynKIR-110 in an interventional trial
Intervention: SynKIR-110 (Drug)
Outcomes
Primary Outcomes
To monitor the long-term safety of participants that have been infused with a SynKIR CAR T cell product
Time Frame: 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
Time Frame: Up to 15 years from SynKIR CAR T cell product administration
Presence of RCL VSV-G DNA
Secondary Outcomes
- To assess the long-term clinical efficacy of SynKIR CAR T cell product(Up to 15 years from SynKIR CAR T cell product administration)
- To assess the persistence of SynKIR-modified T cells(Up to 15 years from SynKIR CAR T cell product administration)