Actively Recruiting
A Long-term Follow-up Study to Assess Safety in Participants Who Received an Investigational T-Cell Receptor Engineered T-Cell (TCR-T) Product
Led by TScan Therapeutics, Inc. · Updated on 2025-09-10
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to monitor participants who previously received TSC-100 or TSC-101 T-cell receptor engineered T-cell (TCR-T) therapies in the TSCAN-001 study. The goal is to assess the long-term safety and efficacy of these investigational treatments over a 15-year period following their administration, focusing on people treated for conditions such as AML, ALL, and MDS. Participants will not receive any new study drug during this long-term follow-up study. Instead, they will be observed after completing the initial TSCAN-001 trial, while continuing any other cancer treatments as necessary. Monitoring will include a period lasting 15 years from the date of their original TCR-T cell therapy. During the study, participants will be evaluated for treatment-emergent adverse events to assess safety and tolerability. Researchers will also monitor overall survival, relapse-free survival, and progression-free survival over the 15 years. This observational study involves regular assessments to track long-term outcomes without administering additional investigational treatments.
CONDITIONS
Brief Title
A Long Term Follow-up Study of TScan TCR-T Products
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
- Signed informed consent.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 15 years
Participants who previously received TCR-T cellular therapy are monitored for safety and efficacy over a next 15 year period without receiving additional study drug.
Trial Site Locations
Total: 2 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Mount Sinai
New York, New York, United States, 10029-6696
Actively Recruiting
Research Team
M
Madhavi Desai
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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