A Long Term Follow-up Study of TScan TCR-T Products

Not yet recruiting

• Conditions: AML; ALL; MDS

• Registration Number: NCT06976736
• Lead Sponsor: TScan Therapeutics, Inc.

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.

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.

Study Timeline

• Study First Submitted: 2025-04-18
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Study Start: 2025-09
• Primary Completion: 2040-09
• Study Completion: 2040-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
• Signed informed consent.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)	15 years post TCR-T administration	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 Outcome Measures

Name	Time	Method
Overall Survival	15 years post TCR-T administration	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	15 years post TCR-T administration	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	15 years post TCR-T administration	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.

Trial Locations

Locations (2)

City of Hope; 🇺🇸 Duarte, California, United States

Mount Sinai; 🇺🇸 New York, New York, United States