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NCT Number: NCT06976736

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

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.

Recruiting

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Key information

Conditions

AML ALL MDS

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Observational

Other

Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 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 outcomes

  1. Overall Survival

    Time frame: 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.

  2. Relapse-free survival

    Time frame: 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.

  3. Progression-free survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madhavi Desai

CONTACT

[email protected]

(857) 399-9832

Sponsors and collaborators

Lead sponsor

TScan Therapeutics, Inc.

Industry

Registry information

Official study 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

Acronym: LTFU

Important dates

Study start
2025
Primary completion
2040
Study completion
2040
First posted
May 16, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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