TerminatedNot applicableNCT05124743
Official study title

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors

Study summary

This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type: * Gynecologic cancer (ovarian or endometrial) * Colorectal cancer * Pancreatic cancer * Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas * Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol. Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Alaunos Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Alaunos Therapeutics
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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 for one of the following cancer types: 1. Gynecologic cancer (ovarian and endometrial) 2. Colorectal cancer 3. Pancreatic cancer 4. Non-small cell lung cancer (NSCLC), NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas 5. Cholangiocarcinoma 2. Patients with previous tumor genomic testing performed at a CLIA-certified laboratory must be willing to disclose results. Patients that do not have previous tumor genomic testing must have a planned biopsy or resection as part of their standard of care (or archived tumor tissue available for genomic testing) or must provide a blood sample for circulating tumor DNA (liquid biopsy) testing. If prior genomic testing results or archival biopsy with sufficient tumor tissue are older than 6 months, a new tumor biopsy is required if being performed as standard-of-care. If re-biopsy is not feasible, a liquid biopsy must be performed to confirm previous test results. 3. Patients with previous high resolution, human leukocyte antigen (HLA) class I and II typing from a CLIA certified laboratory must be willing to disclose results. Patients that do not have previous typing results must be willing to provide a blood sample for this testing. 4. Patients must be able to provide written informed consent. 5. Patients must be age greater than or equal to 18 years. 6. Patients must have a clinical performance status of Eastern Cooperative Oncology Group (ECOG) of 0 or 1. Patients with an ECOG of 2 may be acceptable with Medical Monitor approval.

Reasons someone may not be able to joinExclusion criteria

1. Any other unstable or clinically significant medical condition that would, in the opinion of the Principal Investigator (PI) in consultation as warranted with medical monitor, result in risks to safety of a subject and/or their compliance with the protocol. Examples include, but are not limited to, a history of myocarditis or congestive heart failure (New York Heart Association functional Class III or IV), unstable angina, serious uncontrolled cardiac arrythmia, myocardial infarction within 6 months of screening, active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring chronic treatment with systemic steroids, uncontrolled asthma, or colitis. 2. Any form of primary immunodeficiency (such as severe combined immunodeficiency disease). 3. Has another concurrent clinically active hematologic malignancy or solid tumor malignancy requiring treatment, except for non-melanoma cancers of the skin, carcinoma in situ of the cervix, or non-metastatic prostate cancer. 4. Has a history of a bleeding disorder or unexplained major bleeding diathesis or is currently receiving chronic anticoagulation therapy. 5. Has received any type of organ transplant in the past 12 months. 6. Has undergone xenotransplantation at any time.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.

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