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New treatment option for Breast Cancer
Official title A Study of BRIA-OTS Cellular Immunotherapy in Metastatic Recurrent Breast Cancer
ClinicalTrials.gov ID: NCT06471673
What this study is testing
What is BC1 cell line?
BC1 cell line is an investigational medicine, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label Phase 1/2a study. Once the safety of the BC1 cell line alone has been demonstrated in Phase 1, in Phase 2, patients will be treated with the Bria-OTS regimen (see below) and a clinically available check point inhibitor (CPI).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histological confirmed recurrent metastatic breast cancer which has failed prior therapy defined as:
- Human epidermal growth factor 2 (EGFR2, 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...
- Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and...
- All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available...
You likely can't join if
- Concurrent anti-cancer treatment.
- Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.
- Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
- History of clinical hypersensitivity to the designated therapy, as specified in the protocol or to any components used in the preparation of any cell...
- History of clinical hypersensitivity to any protocol specified therapy.
- 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).
See the full eligibility criteria
- Histological confirmed recurrent metastatic breast cancer which has failed prior therapy defined as:
- Human epidermal growth factor 2 (EGFR2, 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.
- Triple-negative and inflammatory tumors must have exhausted other curative intent therapies including prior treatment with a taxane and platinum-based agent
- All other MBC types must have exhausted other curative intent therapies including any genomic or germline directed targeted therapy having available approved drug(s)
- 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...
- Be 18 years of age or older.
- Have expected survival of at least 4 months.
- Have adequate performance status (up to and including ECOG 2)
- Patients must be stable with all known or expected toxicities from previous treatment including:
- Prior immune related toxicity must not have exceeded Grade 2 with exception of stable endocrinopathy (endocrinopathy if well-managed, is not exclusionary).
- 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).
- Concurrent anti-cancer treatment.
- Recent chemotherapy, radiotherapy, or other anti-cancer treatment within 3 weeks of first protocol treatment.
- Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
- 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.
- History of clinical hypersensitivity to any protocol specified therapy.
- 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).
- Absolute granulocyte count \< 1000; platelets \<50,000.
- 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.
- Proteinuria \>1+ on urinalysis or \>1 gm/24hr.
- New York Heart Association stage 3 or 4 cardiac disease.
- A pleural or pericardial effusion of moderate severity or worse.
- 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...
- Men who are fertile/reproductively competent, should take appropriate precautions to avoid fathering a child for the duration of the study.
- Women who are pregnant or nursing.
- Patients with concurrent second malignancy.
- Persons with previous malignancies requiring treatment within the past 24 months.
- Patients who have clinical or laboratory features indicative of AIDS and are HIV positive (by self-report).
- 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...
- Patients who are on treatment for an autoimmune disease, unless specifically approved by the Investigator and the Sponsor.
- 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.
- Patients may not be on a concurrent clinical trial, unless approved by Investigator and Sponsor.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Monica, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.