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

TScan Therapeutics

Status: Begins enrollment this month

Conditions: AML; MDS; ALL

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT06976736

TSCAN-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

1,000 participants in 1 patient group

Observational

Description:

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.

Treatment:

Other: Observational