Humoral immune response to intralymphatic immunotherapy for disseminated melanoma: correlation with clinical response.
S S Ahn, R F Irie, T H Weisenburger...
https://pubmed.ncbi.nlm.nih.gov/7101129Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID06471673
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
Led by BriaCell Therapeutics Corporation · Updated on 2024-08-26
18
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety and effects of a new cellular immunotherapy called BRIA-OTS for patients with metastatic recurrent breast cancer. This open-label Phase 1/2a study first tests increasing doses of the BC1 cell line alone in a few patients to assess safety. Once safety is established, the study evaluates the combination of BC1 with the Bria-OTS regimen and an FDA-approved checkpoint inhibitor (CPI) to explore potential benefits in this patient group. In the initial monotherapy phase, patients receive intradermal doses of BC1 every two weeks for six weeks, with dose escalation among the first three patients if tolerated. After confirming safety, participants receive the Bria-OTS regimen every three weeks, which includes BC1 cell inoculation combined with low-dose cyclophosphamide given 2-3 days prior, peginterferon alpha-2a on the day of inoculation, and the CPI administered according to approved dosing. Phase 2 expands enrollment to assess this combination in more patients. Participants undergo imaging at screening, after the monotherapy phase, and regularly during treatment to monitor tumor response. They may continue treatment if clinical benefit is observed. Safety is closely monitored throughout, including adverse events, laboratory tests, and physical exams. Follow-up includes phone or medical record reviews every three months for up to two years to assess survival and disease progression. Total participation time is approximately 16 weeks for primary outcomes, with extended follow-up for long-term results.
CONDITIONS
Brief Title
A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically confirmed recurrent metastatic breast cancer that has failed prior therapies: at least 2 anti-HER2 treatments for HER2 positive tumors; refractory to hormonal therapy with prior hormone-based regimens for HER2 negative and ER or PR positive tumors; exhausted curative therapies including taxane and platinum agents for triple-negative and inflammatory tumors; exhausted other approved genomic or targeted therapies for other metastatic breast cancer types
- Stable brain metastases without progression for at least 4 weeks and no steroid use for at least 2 weeks prior to first dose
- Expected survival of at least 4 months
- Adequate performance status up to ECOG 2
- Stable toxicities from previous treatments, with prior immune-related toxicity not exceeding Grade 2 except well-managed endocrinopathy
- Toxicity from prior therapy recovered to grade 1 or baseline except for alopecia, treated endocrinopathy, and anemia not requiring transfusion
You will not qualify if you...
- Receiving concurrent anti-cancer treatment
- Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks before starting the study
- Inadequate recovery from surgery-related toxicities before starting study treatment
- History of clinical hypersensitivity to study therapies or any components used in cell line preparations
- Kidney function abnormalities: BUN >30 with creatinine >2 or creatinine clearance <30 mL/min
- Low blood counts: absolute granulocyte count <1000; platelets <50,000
- Liver function abnormalities: bilirubin >2.0; alkaline phosphatase >4 times upper limit of normal; ALT/AST >2 times upper limit of normal, or >5 times if hepatic metastases present
- Significant proteinuria (>1+ on urinalysis or >1 gm/24 hr)
- Severe heart disease (New York Heart Association stage 3 or 4)
- Moderate or worse pleural or pericardial effusion
- Women of childbearing potential not using contraception or without negative pregnancy test
- Fertile men not using contraception during the study
- Pregnant or nursing women
- Concurrent second malignancy
- Previous malignancies treated within last 24 months
- HIV positive or diagnosed immunodeficiency
- Receiving high-dose steroids or immunosuppressive therapy within 21 days prior to first dose
- Treatment for autoimmune disease unless approved
- Severe psychiatric or progressive major medical problems unless approved
- Participation in another clinical trial unless approved
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monotherapy Phase
Duration - 6 weeks
Participants receive intradermal injections of the BC1 cell line every 2 weeks for a total of 4 doses to assess safety and dose tolerance.
4 visits every 2 weeks (in-person)
Combination Phase
Duration - At least 6 weeks (2 cycles), continuing as per clinical benefit
Participants receive the Bria-OTS regimen, which includes pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 cell inoculation, peginterferon alpha-2a, and a checkpoint inhibitor (tislelizumab) on the day of cell inoculation. Treatment is given every 3 weeks.
Visits every 3 weeks (in-person)
Expansion Cohort
Duration - Variable, based on treatment response
Participants receive the Bria-OTS regimen combined with CPI (tislelizumab) every 3 weeks in an expanded group of up to 12 subjects after safety is established in earlier phases.
Visits every 3 weeks (in-person)
Follow-up
Duration - Up to 2 years
Participants are followed for progression-free survival and overall survival by phone or medical record review every 3 months for up to 2 years after treatment ends.
Quarterly follow-up contacts by phone or record review
Trial Site Locations
Total: 1 location
1
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
Actively Recruiting
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Research Team
T
Tamar Aghajanian, PharmD
B
Blaise Bayer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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