Trial · NCT06471673
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
NCT06471673, Phase 1, Phase 2, Unknown, BriaCell Therapeutics Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer. Trials, record NCT06471673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06471673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
- NCT number
- NCT06471673
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, estimated
- Lead sponsor
- BriaCell Therapeutics Corporation
- Conditions
- Breast Cancer, Breast Tumor, Cancer of Breast, Cancer of the Breast, Malignant Tumor of Breast, Tumors, Breast
- Interventions
- BC1 cell line, Bria-OTS regimen and CPI (tislelizumab), Bria-OTS regimen and CPI (tislelizumab) expansion cohort
- First posted
- 2024-06-24
- Last updated
- 2024-08-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety as assessed by adverse events (AEs), including serious adverse events (SAEs) | Throughout study period plus 4 weeks, approximately 16 weeks total | Total number of AEs |
| Primary | 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) | Throughout study period plus 4 weeks, approximately 16 weeks total | To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters |
| Primary | Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety] | Throughout study period plus 4 weeks, approximately 16 weeks total | To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval |
| Primary | Evaluate the proportion of patients with abnormal physical examination findings including vital signs | Throughout study period plus 4 weeks, approximately 16 weeks total | To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs |
| Secondary | Tumor response as assessed by Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Throughout study period plus 4 weeks, approximately 16 weeks total | Quantify tumor ORR |
| Secondary | Tumor response as assessed by Clinical response rate as determined by local standard of care imaging and investigators | Throughout study period plus 4 weeks, approximately 16 weeks total | Determine clinical relevance of tumor response |
| Secondary | Tumor response as assessed by Non-progressive rate (aka: clinical benefit rate), defined as CR, PR, or stable disease (SD) per RECIST 1.1 and as determined by local standard of care imaging and investigators | Throughout study period plus 4 weeks, approximately 16 weeks total | Quantify change in tumor rate of progression |
| Secondary | Tumor response as assessed by Duration of response (DoR) | Throughout study period plus 4 weeks, approximately 16 weeks total | Quantify tumor duration of response to therapy |
| Other | PFS and OS treated with HLA-characterized cellular immunotherapy | Throughout study period plus 4 weeks, approximately 16 weeks total | To evaluate the effect of the BC1 on progression-free survival (PFS) • To assess the single agent activity of the BC1 regimen in the sample cohort using PFS, ORR, and CBR, and changes in circulating tumor cells before and after therapy. |
| Other | Evaluate Immune Responses | Throughout study period plus 4 weeks, approximately 16 weeks total | Immune responses will be evaluated by known and hypothesized covariates including DTH |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers79
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06471673
GET https://conductscience.org/api/trials/v1/NCT06471673/papers?page=2