ALL, AML, MDS
Conditions
Keywords
TSCAN, Cell Therapies, TCR-T Cell Therapy, Long Term Follow-Up (LTFU), TSC-101, TSC-100, TSCAN-001
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.
Interventions
OTHERObservational
Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products
Sponsors
TScan Therapeutics, Inc.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics. * Signed informed consent.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactMadhavi Desai
Outcome results
None listed