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NCT05124743 · ClinicalTrials.gov registry record
HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
A clinical trial, sponsored by Alaunos Therapeutics.
- Terminated
- Registry status
- 19
- Enrollment target
NCT05124743: Clinical Trial study, sponsored by Alaunos Therapeutics.
NCT05124743 is a clinical trial that was terminated before completion, run by Alaunos Therapeutics. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05124743 was terminated before completion, sponsored by Alaunos Therapeutics.
- TERMINATED
- Registry status
- 19 participants
- Enrollment target
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.
Primary Outcome
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)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2023-08-14 |
Why NCT05124743 stopped before completion
NCT05124743 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05124743 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05124743 about?
NCT05124743 is a clinical study titled "HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors". 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 initia...
What is the current status of trial NCT05124743?
This trial is currently terminated. The enrollment target is 19 participants. The study started on 2021-09-24. Estimated completion is 2023-08-14.
Who is sponsoring clinical trial NCT05124743?
This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.
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