Gynecologic CancerPhase 1/2NCT05194735

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors

A Phase 1/2 study testing Neoantigen specific TCR-T cell drug product and Aldesleukin (IL-2) in people with Gynecologic Cancer and Colorectal Cancer, run by Alaunos Therapeutics at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

A Phase I/II study of autologous T cells engineered using the Sleeping Beauty transposon/transposase system to express TCR(s) reactive against neoantigens in subjects with relapsed/refractory 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 and Aldesleukin (IL-2)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2022to 14 Aug 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Patients who have completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002) and for whom a TCR(s) matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' Clinical TCR library
Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment. Specifically:
Subgroup 1. Gynecologic cancers (i.e., ovarian or endometrial):
Ovarian cancer
Endometrial cancer
Subgroup 2. Colorectal cancer

Show all 19Show fewer

Subgroup 3. Pancreatic cancer
Subgroup 4. Non-small cell lung cancer (NSCLC)
Subgroup 5. Cholangiocarcinoma
Patients must have evaluable or measurable disease per RECIST 1.1 with at least one lesion that can be measured that is not the biopsied lesion.
Patients must be able to provide written informed consent.
Patients must be age ≥ 18 years.
Clinical Performance Status of ECOG 0 or 1. Approval from the Alaunos Medical Monitor is required for ECOG of 2.
Patient must be willing and able to provide written informed consent for the long-term follow-up protocol (TCR001-202) for up to 15 years post TCR-T Cell drug product infusion per FDA requirements.
Adequate bone marrow reserves as assessed by the following hematology laboratory criteria:
Adequate major organ system function
A washout period must have elapsed since completion of any prior systemic therapy, and apheresis with guidelines as follows (windows other than what is listed below should be allowed only after consultation with the Medical Monitor); subjects' non-hematologic toxicities from any prior systemic therapy must have recovered to ≤ Grade 1 (with the exception of neuropathy and alopecia) or baseline prior to starting the protocol's therapy.
Patients may have undergone minor surgical procedures or limited-field radiotherapy provided any major organ toxicities have recovered to ≤ Grade 1.
Female patients must not be pregnant or breastfeeding.

Who cannot join

Patients with known active CNS metastases
Concurrent systemic steroid therapy
Any form of primary immunodeficiency
Patients who have decreased immune competence
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, aldesleukin or bendamustine
Severe chronic respiratory condition

Show all 14Show fewer

History of a bleeding disorder or unexplained major bleeding diathesis
Arm B Criteria only: Clinically significant patient history which in the judgment of the principal investigator (PI) would compromise the subject's ability to tolerate high-dose aldesleukin;
Any major bronchial occlusion or bleeding not amenable to palliation.
Patients with psychiatric illness/social situations at the time of treatment that would limit compliance with study requirements.
Participants with known active, uncontrolled bacterial, fungal, or viral infection
Patients with a prior history or concurrent malignancy
Active unstable or clinically significant medical condition
History of any major cardiovascular conditions within the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

MD Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: 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

An HLA Typing and Tumor Neoantigen Mutation Testing Protocol (Protocol # TCR001-002) has been used to identify patients for potential enrollment into this Study Protocol. Subjects who have completed the HLA Typing and Tumor Neoantigen Mutation Testing Protocol, i.e., subjects for whom a TCR matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' TCR library will be eligible for enrollment on this study.

The Phase I part of this study is a prospective, open-label, dose-escalation study of TCR-T cell drug product in patients with progressive or recurrent solid tumors who have failed standard therapy. The Phase II part is a prospective, open-label, single dose portion of the study. The Phase II part will begin once the MTD/RP2D in the Phase I part has been determined.

Subjects with one of the following histologically confirmed solid tumors will be included:

Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)
Cohort 2: Colorectal cancer
Cohort 3: Pancreatic cancer
Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
Cohort 5: Cholangiocarcinoma

Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation \& HLA type):

KRAS G12D \& HLA-A*11:01
KRAS G12D \& HLA-C*08:02
KRAS G12V \& HLA-A*11:01
KRAS G12V \& HLA-C*01:02
TP53 R175H \& HLA-A*02:01
TP53 R175H \& HLA-DRB1*13:01
TP53 R248W \& HLA-A*68:01
TP53 Y220C \& HLA-A*02:01
TP53 Y220C \& HLA-DRB3*02:02
EGFR E746-A750del \& HLA-DPA1*02:01, DPB1*01:01

Conditions: Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer
Being tested: Neoantigen specific TCR-T cell drug product, Aldesleukin (IL-2)
Keywords: adoptive cell therapy, neoantigen, T cell receptor, T lymphocyte, TCR-engineered T cells, cell therapy, immunotherapy, IL-2, Gene therapy
Medical subject headings: Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Cholangiocarcinoma, Ovarian Neoplasms, Endometrial 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
Phase I:
Ascending dose, single Infusion of TCR+ Cells
Phase II:
Single infusion at the RP2D
Aldesleukin (IL-2)Biological
To support growth and activation of TCR-T cell drug product

Study groups in NCT05194735
Study group	Role	What they receive
TCR-T Cell Drug Product	Experimental	Phase I: Dose-escalation of TCR-T Cell Drug Product Phase II: Single dose of TCR-T Cell Drug Product after MTD/RP2D determine in Phase I portion of the study Receives: Biological: Neoantigen specific TCR-T cell drug product
TCR-T Cell Drug Product with Aldesleukin (IL-2)	Experimental	Phase I: Dose-escalation of TCR-T Cell Drug Product with Aldesleukin (IL-2) Phase II: Single dose of TCR-T Cell Drug Product with Aldesleukin (IL-2) after MTD/RP2D determine in Phase I portion of the study Receives: Biological: Neoantigen specific TCR-T cell drug product; Biological: Aldesleukin (IL-2)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events
Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
Measured: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.
Frequency of Dose Limiting Toxicities
Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Measured: From Day 0 to Day 28 post TCR-T cell drug product infusion.
Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.
Measured: From Day 0 to Day 28 post TCR-T cell drug product infusion.

Secondary outcomes (3)

Feasibility of TCR-T Cell Drug Product Manufacturing
Feasibility will be assessed by the number of participants who met eligibility criteria at each step of the manufacturing process, including inability to undergo apheresis, failure of product manufacture, manufactured product not infused, and successful manufacture and infusion of TCR-T cell drug product.
Measured: From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
TCR-T Cell Persistence
Persistence of TCR-T cells in peripheral blood was assessed by quantitative PCR for vector copy number per 1 × 10⁶ cells at baseline (1 week prior to infusion), predose (Day 0), and multiple post-infusion time points through Month 18. Only quantifiable values are summarized. Samples with "Not Detected (ND)" or "Below the Limit of Quantitation (BLOQ)" are reported as NA and excluded from summary statistics.
Measured: Baseline through Month 18 post-infusion.
Percent Change in TCR-T Cell Count From Post Dose to Day 28
Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
Measured: Post-dose through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202214 Aug 2023

First posted18 Jan 2022
Study start4 Apr 2022
Primary completion14 Aug 2023
Study completion14 Aug 2023

Why it stopped: Funding

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05194735
Sponsor's protocol ID: TCR001-201
Status last verified: Oct 2025
First submitted: 6 Dec 2021
Last updated: 10 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Levy PL, Gros A. Fast track to personalized TCR T cell therapies. Cancer Cell. 2022 May 9;40(5):447-449. doi: 10.1016/j.ccell.2022.04.013. Epub 2022 May 9.
PubMed 35537408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gynecologic Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05194735
Acronym / sponsor ID: TCR001-201
Conditions: Gynecologic Cancer, Colorectal Cancer, Pancreatic Cancer, Non-small Cell Lung Cancer, Cholangiocarcinoma, Ovarian Cancer
Keywords: adoptive cell therapy, neoantigen, T cell receptor, T lymphocyte, TCR-engineered T cells, cell therapy, immunotherapy, IL-2
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding
Enrolment: 8 participants (actual)
Lead sponsor: Alaunos TherapeuticsIndustry (pharma, biotech, devices)
Study start: 4 Apr 2022 (actual)
Primary completion: 14 Aug 2023 (actual)
Study completion: 14 Aug 2023 (actual)
First posted: 18 Jan 2022 (actual)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects with one of the following histologically confirmed solid tumors will be included:

Cohort 1: Gynecologic cancer (e.g., ovarian, endometrial)
Cohort 2: Colorectal cancer
Cohort 3: Pancreatic cancer
Cohort 4: Non-small cell lung cancer (NSCLC); NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
Cohort 5: Cholangiocarcinoma

Subject must have a tumor mutation and HLA typing combination that matches to at least one of the following TCRs in the Alaunos' library (mutation \& HLA type):

KRAS G12D \& HLA-A*11:01
KRAS G12D \& HLA-C*08:02
KRAS G12V \& HLA-A*11:01
KRAS G12V \& HLA-C*01:02
TP53 R175H \& HLA-A*02:01
TP53 R175H \& HLA-DRB1*13:01
TP53 R248W \& HLA-A*68:01
TP53 Y220C \& HLA-A*02:01
TP53 Y220C \& HLA-DRB3*02:02
EGFR E746-A750del \& HLA-DPA1*02:01, DPB1*01:01

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TCR-T Cell Drug Product	Experimental	Biological: Neoantigen specific TCR-T cell drug productPhase I: Dose-escalation of TCR-T Cell Drug Product Phase II: Single dose of TCR-T Cell Drug Product after MTD/RP2D determine in Phase I portion of the study
TCR-T Cell Drug Product with Aldesleukin (IL-2)	Experimental	Biological: Neoantigen specific TCR-T cell drug product, Biological: Aldesleukin (IL-2)Phase I: Dose-escalation of TCR-T Cell Drug Product with Aldesleukin (IL-2) Phase II: Single dose of TCR-T Cell Drug Product with Aldesleukin (IL-2) after MTD/RP2D determine in Phase I portion of the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

Patients who have completed the HLA Typing and Tumor Neoantigen Identification Protocol (TCR001-002) and for whom a TCR(s) matching the subject's somatic mutation(s) and HLA type restriction combination is available in Alaunos' Clinical TCR library
Patients who have previously received at least one line of standard systemic therapy for their advanced/metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment. Specifically:
Patients must have evaluable or measurable disease per RECIST 1.1 with at least one lesion that can be measured that is not the biopsied lesion.
Patients must be able to provide written informed consent.
Patients must be age ≥ 18 years.

Key exclusion criteria (14 listed)

Patients with known active CNS metastases
Concurrent systemic steroid therapy
Any form of primary immunodeficiency
Patients who have decreased immune competence
History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, aldesleukin or bendamustine

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 productPhase I: Ascending dose, single Infusion of TCR+ Cells Phase II: Single infusion at the RP2D	Biological	TCR-T Cell Drug Product, TCR-T Cell Drug Product with Aldesleukin (IL-2)
Aldesleukin (IL-2)To support growth and activation of TCR-T cell drug product	Biological	TCR-T Cell Drug Product with Aldesleukin (IL-2)

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events
Time frame: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.
Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.
Frequency of Dose Limiting Toxicities
Time frame: From Day 0 to Day 28 post TCR-T cell drug product infusion.
Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)
Time frame: From Day 0 to Day 28 post TCR-T cell drug product infusion.
The MTD and/or RP2D was to be determined based on dose-limiting toxicities observed during the dose-escalation phase. The planned definition required ≥2 patients at a given dose level to experience a DLT to declare that dose not tolerated.

3 secondary outcomes

Feasibility of TCR-T Cell Drug Product Manufacturing
Time frame: From apheresis collection to the release of the final TCR-T cell drug product for infusion, estimated to be approximately 5 weeks
TCR-T Cell Persistence
Time frame: Baseline through Month 18 post-infusion.
Percent Change in TCR-T Cell Count From Post Dose to Day 28
Time frame: Post-dose through Day 28

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1	1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	13	7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)	0	0

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events

Time frame: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.. Number. Unit: participants

Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n = 1	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n = 7	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) n = 0
Any TEAE	1	7	–
Drug-related TEAE	1	7	–
Drug-related Grade 3 or higher TEAE	1	6	–
TEAE leading to death	0	0	–
Treatment-emergent SAE	1	2	–

Population analysed: Participants who received a TCR-T cell infusion (Safety Analysis Set).

Primary outcome: Frequency of Dose Limiting Toxicities

Time frame: From Day 0 to Day 28 post TCR-T cell drug product infusion.. Count of participants. Unit: Participants

Measure	Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) n = 1	Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) n = 7	Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) n = 0
Value	0	0	–

Population analysed: Participants who received the planned TCR-T cell infusion and either experienced a DLT or completed the 28-day DLT observation period; those with major protocol deviations unrelated to safety during this period were considered non-evaluable.

Primary outcome: Determination of Maximum Tolerated Dose (MTD) or Recommended Phase II Dose (RP2D)

Time frame: From Day 0 to Day 28 post TCR-T cell drug product infusion.. Number. Unit: Dose level of TCR-T cells infused

Measure	All Dose Levels (DLT-Evaluable Population) n = 8
Value	NA

Population analysed: All participants who received a TCR-T infusion and were monitored for DLTs were included in a single analysis population. Eight participants were infused (6 at Dose Level 1, 2 at Dose Level 2). The MTD/RP2D could not be determined because the study closed early before enough evaluable participants were treated to allow formal determination.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1 of 1 (100%)	1 of 1 (100%)	1 of 1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	2 of 7 (28.6%)	7 of 7 (100%)	6 of 7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35537408Levy PL, Gros A. Fast track to personalized TCR T cell therapies. Cancer Cell. 2022 May 9;40(5):447-449. doi: 10.1016/j.ccell.2022.04.013. Epub 2022 May 9.
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. 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?

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 19 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Nov 2025. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (time frame: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05194735, which also lists 1 linked publication.

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 Nov 2025.