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A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
NCT06471673 · View on ClinicalTrials.gov ↗
Study Summary
This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI). During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence. Following the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s). During the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.
Conditions Studied
Interventions
- BIOLOGICAL BC1 cell line
- BIOLOGICAL Bria-OTS regimen and CPI (tislelizumab)
- BIOLOGICAL Bria-OTS regimen and CPI (tislelizumab) expansion cohort
Study Locations (1)
California
- Sarcoma Oncology Center — Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2025-10-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06471673
The ClinicalTrials.gov registry entry for NCT06471673 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BriaCell Therapeutics Corporation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions — of which BC1 cell line is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06471673 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06471673 about?
NCT06471673 is a clinical study titled "A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer". This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI). During the monotherapy phase of Phase 1, one patien...
What is the current status of trial NCT06471673?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-05-29. Estimated completion is 2025-10-30.
What conditions does trial NCT06471673 study?
This clinical trial studies the following conditions: Breast Cancer, Cancer of the Breast, Cancer of Breast, Breast Tumor, Tumors, Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06471673?
The interventions under investigation include: BC1 cell line (BIOLOGICAL), Bria-OTS regimen and CPI (tislelizumab) (BIOLOGICAL), Bria-OTS regimen and CPI (tislelizumab) expansion cohort (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06471673?
This trial is sponsored by BriaCell Therapeutics Corporation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06471673 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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