AMLLTFUNCT06976736
A Long Term Follow-up Study of TScan TCR-T Products
An observational study of AML and ALL, run by TScan Therapeutics, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2025to Sep 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who received TSC-100 or TSC-101 cellular therapies.
Who may be able to join
- Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
- Signed informed consent.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Monzr M Al Malki, MD
Monzr M Al Malki, MD
- Recruiting
Mount Sinai
New York, New York, 10029-6696
Alla Keyzner, MD
Alla Keyzner, MD
About this study
Official 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
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.
Read the 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.
- Being tested
- Observational
- Keywords
- TSCAN, Cell Therapies, TCR-T Cell Therapy, Long Term Follow-Up (LTFU), TSC-101, TSC-100, TSCAN-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Long Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years post TCR-T administration
Secondary outcomes (3)
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.
Measured: 15 years post TCR-T administration
Relapse-free survival
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.
Measured: 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.
Measured: 15 years post TCR-T administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start9 Sep 2025 (estimated)
- Primary completionSep 2040 (estimated)
- Study completionSep 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TScan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Matzko, MD, Study director, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976736
- Sponsor's protocol ID
- TSCAN-004
- Acronym
- LTFU
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06976736
- Acronym / sponsor ID
- LTFU / TSCAN-004
- Keywords
- TSCAN, Cell Therapies, TCR-T Cell Therapy, Long Term Follow-Up (LTFU), TSC-101, TSC-100, TSCAN-001
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- TScan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (estimated)
- Primary completion
- Sep 2040 (estimated)
- Study completion
- Sep 2040 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: ObservationalNo 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who received TSC-100 or TSC-101 cellular therapies.
Key inclusion criteria (2 listed)
- Participants who received a TCR-T cellular therapy in a clinical study sponsored by TScan Therapeutics.
- Signed informed consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalLong Term Follow-Up for participants treated with TSC-100 or TSC-101 TCR-T products | Other | Observational |
Primary outcome
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.
3 secondary outcomes
Overall Survival
Time frame: 15 years post TCR-T administration
Relapse-free survival
Time frame: 15 years post TCR-T administration
Progression-free survival
Time frame: 15 years post TCR-T administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Matzko, MD study director
Medical Monitor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AML and ALL, run by TScan Therapeutics, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madhavi Desai ((857) 399-9832, medicalaffairs@tscan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: 15 years post TCR-T administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.