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

  • STATUS
    Recruiting
  • End date
    May 28, 2028
  • participants needed
    2000
  • sponsor
    Alaunos Therapeutics
Updated on 11 August 2022
cancer
systemic therapy
measurable disease
carcinoma
squamous cell carcinoma
lung cancer
adenosquamous carcinoma
brain metastases
recurrent disease
liquid biopsy
line of therapy
gynecologic cancer
lung carcinoma

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.

Description

This protocol will be used to perform and/or collect results from genetic mutation testing (e.g., Oncomine™ or similar genomic test performed at a CLIA-certified laboratory) and high resolution, human leukocyte antigen (HLA) class I and II typing from a CLIA-certified laboratory. This protocol will also collect subject clinical baseline characteristics, demographics, and cancer history. This protocol will be used to monitor subject disease status to identify candidates for enrollment onto the Phase I/II study as patients must have progressive or recurrent disease to be enrolled onto that protocol.

The subject's somatic mutation(s) and HLA type restriction combination will be examined against Alaunos' TCR library to determine if a TCR is available for that subject. Subjects without a TCR match will be discontinued from this protocol. If the subject's somatic mutation and HLA type restriction combination matched TCR is added to the Alaunos TCR library after the subject discontinues, the investigator may contact the subject to be re-screened for the study.

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, particularly progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Clinical status will be collected at enrollment and approximately every 3 months in conjunction with subjects' regularly scheduled standard of care visits. Subjects with a TCR match will complete participation on this protocol once they enroll in the Phase I/II study or if the subject dies.

Details
Condition Ovarian Cancer, Endometrial Cancer, Colo-rectal Cancer, Cholangiocarcinoma, Non-small Cell Lung Cancer, Pancreas Cancer
Clinical Study IdentifierNCT05124743
SponsorAlaunos Therapeutics
Last Modified on11 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
tissue are older than 6 months, a new tumor biopsy is required if being
Patients must be able to provide written informed consent
performed as standard-of-care. If re-biopsy is not feasible, a liquid biopsy
must be performed to confirm previous test results
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

Exclusion Criteria

Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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