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A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer

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NCT06471673

Sponsored by BriaCell Therapeutics Corporation (industry) · BCTX — their whole pipeline →.

Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
18estimated
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-05-29actualWhen the study began enrolling
Primary completion2025-04-30estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-10-30estimatedThe whole study's end, after follow-up
First posted2024-06-24actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2024-08-26actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Breast Cancer
  • Breast Tumor
  • Cancer of Breast
  • Cancer of the Breast
  • Malignant Tumor of Breast
  • Tumors, Breast

Interventions

  • Biological: BC1 cell line
  • Biological: Bria-OTS regimen and CPI (tislelizumab)
  • Biological: Bria-OTS regimen and CPI (tislelizumab) expansion cohort

Primary outcomes

what the primary-completion date above is the date OF
Safety as assessed by adverse events (AEs), including serious adverse events (SAEs)
measured Throughout study period plus 4 weeks, approximately 16 weeks total
Evaluate the Proportion of Patients with Abnormalities in Safety Laboratory Parameters that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab)
measured Throughout study period plus 4 weeks, approximately 16 weeks total
Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety]
measured Throughout study period plus 4 weeks, approximately 16 weeks total
Evaluate the proportion of patients with abnormal physical examination findings including vital signs
measured Throughout study period plus 4 weeks, approximately 16 weeks total

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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