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

NCT06471673 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BC-OTS-001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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). During the monotherapy phase of Phase 1, one patient will be treated intradermally every 2 weeks for 6 weeks (4 doses) with an initial dose of the BC1 cell line. If this dose is tolerated, the next patient will receive an increased dose of BC1. If once again tolerated, the third patient will receive a further dose increase of the BC1. Once at least 3 patients have been safely treated with the BC1 cell line, with no dose-limiting toxicity (DLT), the combinational phase of the study will commence. Following the monotherapy phase, patients will be treated with BC1 and the Bria-OTS regimen (see below) every 3 weeks, plus a CPI at the FDA approved labelled dose and schedule. There will be at least a 2-week spacing between enrollment of each of the first three subjects in the study in order to assess for any early unanticipated risk(s). During the Phase 1 combination and Phase 2 expansion phases, all patients will be treated with BC1 cells as part of the Bria-OTS regimen, which includes cyclophosphamide 300 mg/m2 2-3 days prior to BC1 cell inoculation, and peginterferon alpha-2a administered on the same day, following BC1 cell inoculation.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Safety as assessed by adverse events (AEs), including serious adverse events (SAEs)

  Total number of AEs

  Throughout study period plus 4 weeks, approximately 16 weeks total

• 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)

  To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Evaluate changes in the electrocardiogram QT interval that occur in patients treated with BC1 and BC1 administered in combination with CPI (tislelizumab). [Safety]

  To evaluate the safety of BC1 as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Evaluate the proportion of patients with abnormal physical examination findings including vital signs

  To evaluate the safety of BC1 as assessed by: o The Proportion of Patients with Abnormalities in Physical Examination Findings and Abnormal Vital Signs

  Throughout study period plus 4 weeks, approximately 16 weeks total

Secondary Outcomes (4)

• Tumor response as assessed by Objective response rate (ORR), defined as complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Tumor response as assessed by Clinical response rate as determined by local standard of care imaging and investigators

  Throughout study period plus 4 weeks, approximately 16 weeks total

• 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

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Tumor response as assessed by Duration of response (DoR)

  Throughout study period plus 4 weeks, approximately 16 weeks total

Other Outcomes (6)

• PFS and OS treated with HLA-characterized cellular immunotherapy

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Evaluate Immune Responses

  Throughout study period plus 4 weeks, approximately 16 weeks total

• Stratified Analysis of Outcomes by HLA type

  Throughout study period plus 4 weeks, approximately 16 weeks total

Study Arms (3)

Phase 1, Part 1 Monotherapy Phase

EXPERIMENTAL

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.

Biological: BC1 cell line

Phase 1, Part 2 Combination Phase

EXPERIMENTAL

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).

Biological: Bria-OTS regimen and CPI (tislelizumab)

Phase 2 Expansion Cohort

EXPERIMENTAL

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).

Biological: Bria-OTS regimen and CPI (tislelizumab) expansion cohort

Interventions

BC1 cell line BIOLOGICAL

BC1 cell line is a different experimental, HER-2 positive, allogeneic, whole cell BC cell lines designed to secrete GM-CSF in situ and augment dendritic cell activity. Similar to the SV-BR-1-GM cell line (NCT03328026, IND 10312), the BC cell line is derived from the BC parent cell line, SV-BR-1, which expresses multiple tumor associated antigens (TAAs)

Phase 1, Part 1 Monotherapy Phase

Bria-OTS regimen and CPI (tislelizumab) BIOLOGICAL

Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation.

Phase 1, Part 2 Combination Phase

Bria-OTS regimen and CPI (tislelizumab) expansion cohort BIOLOGICAL

Biological: BC1 * BC1 inoculation intradermally at 4 sites Drug: Low dose cyclophosphamide * Pretreatment with low dose cyclophosphamide 2-3 days prior to BC1 inoculation Drug: Interferon * Subjects will receive low dose peginterferon alpha-2a on the same day as cell inoculation. Drug: Tislelizumab * CPI treatment will also be given on the same day as cell inoculation.

Phase 2 Expansion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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 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.
• 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:
• 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).

You may not qualify 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 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.
• 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 study and has a negative serum pregnancy test within 7 days prior to starting treatment.
• 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.

Sponsors & Collaborators

• BriaCell Therapeutics Corporation: lead

Study Sites (1)

Sarcoma Oncology Center

Santa Monica, California, 90403, United States

RECRUITING

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Related Links

• Cyclophosphamide Prescribing Information.
• NCCN Clinical Practice Guidelines in Oncology.
• PEGASYS Prescribing Information
• SEER Cancer Stat Facts: Female Breast Cancer. National Cancer Institute. Bethesda, MD,
• CTCAE v5.0 Toxicity Criteria:

MeSH Terms

Conditions

Breast Neoplasms

Interventions

cyclopropapyrroloindole; tislelizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Giuseppe Del Priore, MD, MPH

  BriaCell Therapeutics Corp

  STUDY CHAIR

• Victoria Chua-Alcala, MD

  Sarcoma Oncology Research Center

  STUDY DIRECTOR

Central Study Contacts

Tamar Aghajanian, PharmD

CONTACT

1-888-485-6340; tamar@briacell.com

Blaise Bayer, MD

CONTACT

1-888-485-6340; blaisebayer@briacell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 24, 2024
• Study Start: May 29, 2024
• Primary Completion: April 30, 2025
• Study Completion: October 30, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)