Gynecologic CancerNCT05292859
Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
An observational study of Gynecologic Cancer and Colorectal Cancer, run by Alaunos Therapeutics at 1 site in United States.
Trial summary
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer
- What is being tested?
- Neoantigen specific TCR-T cell drug product
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2022to 20 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT05194735 or any protocol in which patients were administered Neoantigen specific TCR-T cell drug product. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post TCR-T cell drug product infusion and will continue to be monitored for safety, immunogenicity and efficacy.
Who may be able to join
- Subjects treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.
Who cannot join
- 1. Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors
Read the detailed description
This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).
Follow-up ended after 7 deaths were reported; 1 participant met the study criteria for lack of cell persistence. No participant remained in follow-up at the 06 July 2025 reporting cutoff.
- Conditions
- Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer
- Being tested
- Neoantigen specific TCR-T cell drug product
- Medical subject headings
- Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Ovarian Neoplasms, Adenocarcinoma of Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoantigen specific TCR-T cell drug productBiological
No study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy
| Study group | Role | What they receive |
|---|---|---|
| Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies | This is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies.
Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product. Receives: Biological: Neoantigen specific TCR-T cell drug product |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
Incidence and duration of new related adverse events
Measured: Up to 2 years post TCR-T cell drug product infusion
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
- Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies.
- Incidence and duration of late onset adverse events
- Proportion of subjects with adverse events leading to death
- Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.
Measured: Up to 15 years post TCR-T cell drug product infusion
Secondary outcomes (6)
To investigate translational hypotheses related to TCR-T cell persistence.
Duration of TCR-T cell drug product persistence by vector copy number (VCN).
Measured: Up to 15 years post TCR-T cell drug product infusion
To determine overall survival.
Date of TCR-T cell drug product administration to death
Measured: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Overall response by RECIST 1.1 for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
Measured: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Overall response by iRECIST for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
Measured: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Duration of response (DoR) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
Measured: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Progression-free survival (PFS) for subjects who did not have progressive disease on TCR001-201, proportion of subjects receiving subsequent curative therapies
Measured: Up to 15 years post TCR-T cell drug product infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start7 Oct 2022
- Primary completion20 Apr 2025
- Study completion20 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Kopetz, MD, PhD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292859
- Sponsor's protocol ID
- TCR001-202
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Using the Sleeping Beauty System to Express T Cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT05292859
- Acronym / sponsor ID
- TCR001-202
- Conditions
- Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Alaunos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 20 Apr 2025 (actual)
- First posted
- 23 Mar 2022 (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.
Long-Term Follow-Up Study for Subjects Enrolled in the Phase I/II Study of Autologous T Cells Engineered using the Sleeping Beauty System to Express T cell Receptors (TCRs) Reactive Against Cancer-specific Mutations in Subjects with Solid Tumors
Detailed description
This is a prospective observational, non-interventional study for the long-term follow-up of safety and efficacy for subjects who have received autologous T cells engineered using the Sleeping Beauty System to express T cell receptors (TCRs) reactive against cancer-specific mutations (neoantigen specific TCR-T cells). In this study, subjects will be followed for up to 15 years after initial TCR-T cell drug product administration for evaluation of delayed adverse events (AEs).
Follow-up ended after 7 deaths were reported; 1 participant met the study criteria for lack of cell persistence. No participant remained in follow-up at the 06 July 2025 reporting cutoff.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies | – | Biological: Neoantigen specific TCR-T cell drug productThis is a rollover protocol designed to provide long-term follow-up to all subjects previously enrolled in any Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product interventional studies. Patients will be followed for up to 15 years after dosing of Alaunos Therapeutics autologous, neoantigen specific TCR-T cell drug product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled following either the completion or early termination/discontinuation from Study NCT05194735 or any protocol in which patients were administered Neoantigen specific TCR-T cell drug product. Patients will begin the long-term follow-up period regardless of whether they responded to treatment or progressed on treatment. Patients will be followed for up to 15 years post TCR-T cell drug product infusion and will continue to be monitored for safety, immunogenicity and efficacy.
Key inclusion criteria (4 listed)
- Subjects treated with TCR-T cell drug product on study TCR001-201 or any other Alaunos TCR-T cell drug product study and have either completed their original treatment protocol or have discontinued early.
- Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
- Subject must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Subjects agree to allow clinical samples to be collected and stored at study site and/or Alaunos Therapeutics, Inc. (Alaunos) or designee for testing.
Key exclusion criteria (1 listed)
- 1. Subjects that were consented to this LTFU study but did not receive TCR-T cell drug product on study TCR001-201 will be excluded. No other exclusions are permitted.
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 |
|---|---|---|
| Neoantigen specific TCR-T cell drug productNo study drug is administered in this study. Patients who have received Neoantigen specific TCR-T cell drug product will be evaluated in this trial for long-term safety and efficacy | Biological | Rollover subjects from Alaunos Therapeutics TCR-T cell drug product interventional studies |
Primary outcome
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
Time frame: Up to 2 years post TCR-T cell drug product infusion
Incidence and duration of new related adverse events
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells
Time frame: Up to 15 years post TCR-T cell drug product infusion
* Incidence and duration of events of special interest, new Serious Adverse Events and new malignancies. * Incidence and duration of late onset adverse events * Proportion of subjects with adverse events leading to death * Incidence of subjects with resolution of adverse events/ serious adverse events and duration of events that began in study TCR001-201 or other clinical trial in which TCR-T cell drug product has been administered.
6 secondary outcomes
To investigate translational hypotheses related to TCR-T cell persistence.
Time frame: Up to 15 years post TCR-T cell drug product infusion
To determine overall survival.
Time frame: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Time frame: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Time frame: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Time frame: Up to 15 years post TCR-T cell drug product infusion
To continue the clinical efficacy assessment of TCR-T cell product.
Time frame: Up to 15 years post TCR-T cell drug product infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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. This study is not recruiting at the moment.
Scott Kopetz, MD, PhD principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Colorectal Cancer, run by Alaunos Therapeutics at 1 site 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 4 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the long-term safety of subjects that have received neoantigen-specific TCR-T cells (time frame: Up to 2 years post TCR-T cell drug product infusion). The study lists 2 primary outcomes in all. 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 15 Oct 2026.