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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 years post TCR-T administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 years post TCR-T administration |
| Relapse-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who received TSC-100 or TSC-101 cellular therapies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madhavi Desai | Contact | (857) 399-9832 | medicalaffairs@tscan.com |
| Name | Affiliation | Role |
|---|---|---|
| Michelle Matzko, MD | Medical Monitor | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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Approximately 20 ml of whole blood will be collected at each visit.
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. |
| 15 years post TCR-T administration |
| 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. | 15 years post TCR-T administration |
| Mount Sinai | Recruiting | New York | New York | 10029-6696 | United States |
|