A Long Term Follow-up Study of TScan TCR-T Products
LTFU
A Long-term Follow-up Study to Assess Safety in Participants Who Received an Investigational T-Cell Receptor Engineered T-Cell (TCR-T) Product
1 other identifier
observational
1,000
1 country
2
Brief Summary
The purpose of this Long-Term Follow-Up (LTFU) study is to monitor participants who have previously received TSC-100 or TSC-101 TCR-T therapies in the TSCAN-001 study. Participants will be monitored for 15 years from the date of TCR-T cell therapy administration to assess long-term safety and efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2025
CompletedFirst Posted
Study publicly available on registry
May 16, 2025
CompletedStudy Start
First participant enrolled
September 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2040
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2040
September 10, 2025
September 1, 2025
15 years
April 18, 2025
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
To assess the long-term safety of TSC-100 and TSC-101 in participants by evaluating the incidence, duration, and outcome of adverse events and adverse events of special interest.
15 years post TCR-T administration
Secondary Outcomes (3)
Overall Survival
15 years post TCR-T administration
Relapse-free survival
15 years post TCR-T administration
Progression-free survival
15 years post TCR-T administration
Study Arms (1)
Observational
No study drug will be administered during this trial. Participants previously treated with TSC-100 or TSC-101 in a TScan study will be evaluated for long-term safety and efficacy.
Interventions
Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products
Eligibility Criteria
Participants who received TSC-100 or TSC-101 cellular therapies.
You may qualify if:
- Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
- Signed informed consent.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
City of Hope
Duarte, California, 91010, United States
Mount Sinai
New York, New York, 10029-6696, United States
Biospecimen
Approximately 20 ml of whole blood will be collected at each visit.
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michelle Matzko, MD
Medical Monitor
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2025
First Posted
May 16, 2025
Study Start
September 9, 2025
Primary Completion (Estimated)
September 1, 2040
Study Completion (Estimated)
September 1, 2040
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share