BRIA-OTS Cellular Immunotherapy for Metastatic Recurrent Breast Cancer

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

This study is testing a new immunotherapy treatment for people with metastatic recurrent breast cancer to see if it is safe and effective.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BriaCell Therapeutics Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone, cyclophosphamide
• Locations: 1 site (Santa Monica, California)
• Trial ID: NCT06471673 on ClinicalTrials.gov

What this trial studies

This open-label Phase 1/2a study evaluates the safety and efficacy of the BC1 cell line in patients with metastatic recurrent breast cancer. Initially, patients will receive the BC1 cell line intradermally every two weeks for six weeks to assess safety. If tolerated, the study will progress to a combination phase where patients will receive the BC1 cell line along with the Bria-OTS regimen and a checkpoint inhibitor every three weeks. The study aims to determine the optimal dosing and therapeutic effects of this innovative immunotherapy approach.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed recurrent metastatic breast cancer who have failed prior therapies.

Not a fit: Patients with early-stage breast cancer or those who have not yet undergone standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new immunotherapy option for patients with advanced breast cancer who have exhausted other treatment options.

How similar studies have performed: While there have been studies on immunotherapy for breast cancer, the specific combination of BC1 and the Bria-OTS regimen is a novel approach that has not been extensively tested.

Eligibility criteria

Key Inclusion Criteria:

1. Histological confirmed recurrent metastatic breast cancer which has failed prior

   therapy defined as:
   1. Human epidermal growth factor 2 (EGFR2, HER2) positive tumors must have failed therapy with at least 2 anti-HER2 agents
   2. 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.
   3. Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent
   4. All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)
   5. Patients with new or progressive breast cancer metastatic to the brain will be eligible, provided:

   i. The brain metastases must be clinically stable (without evidence of progressive disease by imaging) for at least 4 weeks, prior to first dose.

   ii. There is no need for steroids and patients have not had steroids for at least 2 weeks prior to the first dose.
2. Be 18 years of age or older.
3. Have expected survival of at least 4 months.
4. Have adequate performance status (up to and including ECOG 2)
5. Patients must be stable with all known or expected toxicities from previous treatment including:

   1. Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).
   2. Toxicity of prior therapy that has not recovered to ≤ grade 1 or baseline (with the exception of any grade of alopecia, adequately treated endocrinopathy, and anemia not requiring transfusion support).

Exclusion Criteria:

1. Concurrent anti-cancer treatment.
2. Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.
3. Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
4. History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell line in this study.
5. History of clinical hypersensitivity to any protocol specified therapy.
6. BUN \>30 in conjunction with a creatinine \>2, or calculated creatinine clearance (CrCl) \<30 mL/min (GFR can be used in place of creatinine or CrCl).
7. Absolute granulocyte count \< 1000; platelets \<50,000.
8. Bilirubin \>2.0; alkaline phosphatase \>4x upper limit of normal (ULN); ALT/AST \>2x ULN. For patients with hepatic metastases, ALT/AST \>5x ULN is exclusionary.
9. Proteinuria \>1+ on urinalysis or \>1 gm/24hr.
10. New York Heart Association stage 3 or 4 cardiac disease.
11. A pleural or pericardial effusion of moderate severity or worse.
12. Any woman of childbearing potential (i.e., has had a menstrual cycle within the past year and has not been surgically sterilized), unless she: agrees to take appropriate precautions to avoid becoming pregnant during the study and has a negative serum pregnancy test within 7 days prior to starting treatment.
13. Men who are fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
14. Women who are pregnant or nursing.
15. Patients with concurrent second malignancy.
16. Persons with previous malignancies requiring treatment within the past 24 months.
17. Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).
18. Have a diagnosis of immunodeficiency, or is receiving chronic systemic steroid therapy (doses exceeding 10 mg daily of prednisone equivalent), or any other form of immunosuppressive therapy within 21 days prior to first dose of study treatment.
19. Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
20. Patients with severe psychiatric (e.g., schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator and Sponsor.
21. Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.

Where this trial is running

Santa Monica, California

• Sarcoma Oncology Center — Santa Monica, California, United States (Recruiting)

Study contacts

• Study coordinator: Tamar Aghajanian, PharmD

Conditions Breast Cancer; Breast Tumor; Cancer of Breast; Cancer of the Breast; Malignant Tumor of Breast; Tumors, Breast