About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
Signed informed consent.
Disqualifiers
None
Trial population
Participants who received TSC-100 or TSC-101 cellular therapies.
Trial design
Other
Prospective
Treatments tested in this trial
Observational
Other interventionLong Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall Survival
To asses the long-term efficacy of TSC-100 and TSC-101 in participants by evaluating: Overall survival (OS) is defined as the time interval between the date of stem cell transplant or TCR-T cell infusion and death for any cause.
Relapse-free survival
To asses the long-term efficacy of TSC-100 and TSC-101 in participants by evaluating: Relapse-free survival (RFS) is defined as the time from date of transplant in the parent study to death or relapse, whichever comes first.
Progression-free survival
To asses the long-term efficacy of TSC-100 and TSC-101 in participants by evaluating: Progression-free survival (PFS) is defined as the time from date of first TCR-T cell infusion in the parent study to death or disease progression, whichever comes first.
Sponsors and contacts
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