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CAR T-cell Therapy

Bria-OTS Immunotherapy for Breast Cancer

Santa Monica, CA

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

No Placebo-Only Group

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

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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.Check my eligibility

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.See study design

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 below

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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.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study period plus 4 weeks, approximately 16 weeks total for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Secondary study objectives

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

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Other study objectives

Evaluate Immune Responses

PFS and OS treated with HLA-characterized cellular immunotherapy

Second Progression-Free Survival (PFS2) on subsequent therapy

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Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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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