A Long Term Follow-up Study of TScan TCR-T Products
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Observational.
- Who it may be relevant to
- Registry conditions: AML, ALL, MDS. Basic parameters: 18 years — 110 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Long-term Follow-up Study to Assess Safety in Participants Who Received an Investigational T-Cell Receptor Engineered T-Cell (TCR-T) Product
Overview
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.
Detailed description
Participants will enroll in this LTFU study after completing the TSCAN-001 interventional trial. No additional study drug will be administered; however, participants may receive other cancer treatments as needed while being monitored for long-term safety.
Enrollment will occur after completion of the TSCAN-001 study, and participants will be monitored for safety and efficacy over a 15 year period.
Interventions
- Other Observational
Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Time frame: 15 years post TCR-T administration]
Secondary outcome measures (3)
- Overall Survival [Time frame: 15 years post TCR-T administration]
- Relapse-free survival [Time frame: 15 years post TCR-T administration]
- Progression-free survival [Time frame: 15 years post TCR-T administration]
Eligibility criteria
Inclusion criteria
- Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
- Signed informed consent.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 2 centers
- City of Hope — Duarte
- Mount Sinai — New York
Identifiers
NCT: NCT06976736 · TSCAN-004