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CAR T-cell Therapy
Bria-OTS Immunotherapy for Breast Cancer
Phase 1 & 2
Recruiting
Research Sponsored by BriaCell Therapeutics Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
HER2 positive tumors must have failed therapy with at least 2 anti-HER2 agents
HER2 negative and either ER or PR positive tumors must be refractory to hormonal therapy and previously treated with at least 2 hormone-based targeted therapy containing regimens
Must not have
Concurrent anti-cancer treatment
BUN >30 in conjunction with a creatinine >2, or calculated creatinine clearance (CrCl) <30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study period plus 4 weeks, approximately 16 weeks total
Awards & highlights
Summary
"This trial is testing the safety and effectiveness of a new treatment called the Bria-OTS regimen for patients with certain types of cancer. In the first phase, patients will be treated with the BC1
Who is the study for?
This trial is for individuals with metastatic recurrent breast cancer. Participants should be able to receive intradermal injections and have no history of severe reactions to immunotherapies. They must not have received certain treatments recently and should be in stable condition without rapidly progressing disease.
What is being tested?
The study tests the safety and effectiveness of BRIA-OTS cellular immunotherapy, first alone (BC1 cell line) then combined with a checkpoint inhibitor (CPI), tislelizumab. It starts with increasing doses of BC1, followed by a combination treatment including cyclophosphamide and peginterferon alpha-2a.
What are the potential side effects?
Potential side effects may include skin reactions at injection sites, flu-like symptoms from interferon, immune-related responses due to CPIs like inflammation or organ dysfunction, fatigue, nausea, and potential blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My HER2 positive cancer did not respond to at least 2 different HER2 treatments.
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My breast cancer is HER2 negative, hormone receptor positive, and has not responded to at least 2 hormone therapies.
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I have tried all other treatments for my aggressive breast cancer, including taxane and platinum-based therapies.
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I have tried all available treatments for my breast cancer.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer has returned and previous treatments didn't work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently receiving any cancer treatments.
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My kidney function is reduced, with high BUN and creatinine or low clearance.
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My heart condition is severe.
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I am HIV positive with symptoms or lab results indicating AIDS.
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I have not taken steroids or immunosuppressants in the last 21 days.
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I haven't had cancer treatment in the last 3 weeks.
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I have moderate or severe fluid buildup around my lungs or heart.
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I am not pregnant or nursing.
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I have another type of cancer besides the one being treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study period plus 4 weeks, approximately 16 weeks total
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study period plus 4 weeks, approximately 16 weeks total
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety]
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)
Evaluate the proportion of patients with abnormal physical examination findings including vital signs
+1 moreSecondary outcome measures
Tumor response as assessed by Clinical response rate as determined by local standard of care imaging and investigators
Tumor response as assessed by Duration of response (DoR)
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
+1 moreOther outcome measures
Evaluate Immune Responses
PFS and OS treated with HLA-characterized cellular immunotherapy
Second Progression-Free Survival (PFS2) on subsequent therapy
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2 Expansion CohortExperimental Treatment1 Intervention
Once 3 patients have been safely treated with the Bria-OTS regimen and CPI (tislelizumab) for 2 cycles, Phase 2 will enroll an expansion cohort, consisting of up to an additional 9 subjects (for a total of 12 treated with the Bria-OTS regimen and CPI).
The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing.
Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab).
Group II: Phase 1, Part 2 Combination PhaseExperimental Treatment1 Intervention
3 subjects will be treated every 3 weeks with the Bria-OTS regimen with a CPI (tislelizumab) in the Part 2 combination phase.
The Bria-OTS regimen consists of cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell line inoculation. On the same day as the cell inoculation, subjects will receive peginterferon alpha-2a. Subjects will also receive the CPI (tislelizumab) on the same day of the cell inoculation according to approved dosing.
Treatment is administered every 3 weeks in combination with the Bria-OTS regimen and CPI (tislelizumab).
Group III: Phase 1, Part 1 Monotherapy PhaseExperimental Treatment1 Intervention
Subject 1, Q2w for 4 doses
Subject 2, Q2w for 4 doses
Subject 3, Q2w for 4 doses Treatment is administered every 2 weeks for a total of 4 doses.
Initially, safety will be assessed on these 3 subjects. DLTs are defined as CTCAE Grade 3 or 4 adverse events that are suspected to be possibly related to study treatment.
If 1 of 3 Phase 1 subjects experience a DLT, that dose cohort will be expanded to another 3 patients before the combinational phase begins. A total of 3-6 subjects will be assessed for safety.
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Who is running the clinical trial?
BriaCell Therapeutics CorporationLead Sponsor
3 Previous Clinical Trials
464 Total Patients Enrolled
2 Trials studying Breast Cancer
440 Patients Enrolled for Breast Cancer
Giuseppe Del Priore, MD, MPHStudy ChairBriaCell Therapeutics Corp
1 Previous Clinical Trials
23 Total Patients Enrolled
Victoria Chua-Alcala, MDStudy DirectorSarcoma Oncology Research Center
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