Actively Recruiting
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
Led by Minerva Biotechnologies Corporation · Updated on 2023-06-18
69
Participants Needed
1
Research Sites
782 weeks
Total Duration
On this page
Sponsors
M
Minerva Biotechnologies Corporation
Lead Sponsor
C
City of Hope Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Phase I/II study of adoptive immunotherapy for advanced MUC1\* positive breast cancer with autologous T cells engineered to express either a chimeric antigen receptor, huMNC2-CAR44 or huMNC2-CAR22, which are specific for a cleaved form of MUC1 (MUC1\*).
CONDITIONS
Official Title
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of breast cancer with known ER, PR, and HER2 status per guidelines
- Tumors classified into expansion cohorts based on hormone receptor and HER2 status
- Received standard metastatic systemic therapies per guidelines with no limit on prior regimens
- Hormone receptor positive patients must have had at least 3 endocrine therapies and 2 chemotherapy lines
- HER2 positive patients must have received at least 3 HER2-targeted therapies in metastatic setting
- Triple negative patients must have received at least 2 chemotherapy lines in metastatic setting
- MUC1* membrane expression ≥30% by immunohistochemistry on recent or screening tumor specimen
- Age 18 years or older, any gender, race, or ethnicity
- Able to understand and provide written informed consent
- Karnofsky performance status of 60% or higher
- Measurable disease by CT, MRI, or FDG PET imaging
- Negative serum pregnancy test within 14 days before leukapheresis and 28 days before lymphodepleting chemotherapy for women of childbearing potential
- Willingness of fertile male and female patients to use effective contraception before, during, and for 4 months after CAR T cell infusion
You will not qualify if you...
- Ongoing daily corticosteroid therapy above 15 mg prednisone or equivalent (pulsed use acceptable)
- Active autoimmune disease needing immunosuppressive therapy unless discussed with investigator
- Major organ dysfunction including elevated creatinine, bilirubin, liver enzymes, pulmonary dysfunction, or significant heart abnormalities
- Absolute neutrophil count below 1000/mm³
- Hemoglobin below 9 mg/dL (transfusion allowed to meet this)
- Platelet count below 75,000/mm³
- Use of investigational agents within 30 days before planned lymphodepletion
- HIV positive status
- Uncontrolled active infection
- Expected survival less than 3 months
- Breastfeeding women
- Contraindication to cyclophosphamide chemotherapy
- Progressing or actively treated second malignancy
- Untreated central nervous system metastases or carcinomatous meningitis (stable treated brain metastases allowed)
- Psychiatric, social, or medical conditions preventing informed consent or compliance as determined by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010-3000
Actively Recruiting
Research Team
J
Joanne Mortimer, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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