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

NCT05124743 | Terminated DMC

• 1 other identifier: TCR001-002
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Endometrial Cancer; Colo-rectal Cancer; Cholangiocarcinoma; Non-small Cell Lung Cancer; Pancreas Cancer

Keywords

TCR, solid tumor, TCR-T, neoantigen, Alaunos

Outcome Measures

Primary Outcomes (1)

• Number of Participants Positive for Human Leukocyte Antigen (HLA)-A*02

  A blood sample was collected from each consented participant to determine their human leukocyte antigen (HLA) haplotype. This measure reports the number of subjects identified as positive for the HLA-A\*02 allele, which was a key eligibility criterion for potential enrollment into the subsequent treatment protocol (TCR001-201)

  Screening Visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 or 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

You may qualify if:

• 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:
• Gynecologic cancer (ovarian and 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
• 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.
• 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.
• Patients must be able to provide written informed consent.
• Patients must be age greater than or equal to 18 years.
• 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.

You may not qualify if:

• 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.
• Any form of primary immunodeficiency (such as severe combined immunodeficiency disease).
• 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.
• Has a history of a bleeding disorder or unexplained major bleeding diathesis or is currently receiving chronic anticoagulation therapy.
• Has received any type of organ transplant in the past 12 months.
• Has undergone xenotransplantation at any time.

Sponsors & Collaborators

• Alaunos Therapeutics: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Colonic Neoplasms; Cholangiocarcinoma; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pancreatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 18, 2021
• Study Start: September 24, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)