OncoMatch/Clinical Trials/NCT04020575
Autologous huMNC2-CAR44 or huMNC2-CAR22 T Cells for Breast Cancer Targeting Cleaved Form of MUC1 (MUC1*)
Is NCT04020575 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells and huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D for metastatic breast cancer.
Treatment: huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells · huMNC2-CAR44 CAR T cells or huMNC2-CAR22 CAR T cells @ RP2D — 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\*).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: MUC1 cleaved form (MUC1*) membrane expression ≥30% (membrane expression ≥30% by immunohistochemistry)
MUC1* membrane expression ≥30% by immunohistochemistry on a tumor specimen obtained at screening or previous tumor specimen that is less than 6-months old
Allowed: ESR1 expression ≥1%
For dose expansion cohorts, tumors with ER and/or PR ≥1% will be considered hormone receptor positive.
Allowed: PR (PGR) expression ≥1%
For dose expansion cohorts, tumors with ER and/or PR ≥1% will be considered hormone receptor positive.
Allowed: HER2 (ERBB2) positive
HER2 status will be determined by IHC or FISH per ASCO/CAP guidelines.
Disease stage
Metastatic disease required
Prior therapy
Must have received: systemic therapy — metastatic
Patients must have received standard metastatic systemic therapy per NCCN guidelines or institutional practice which are known to confer benefit.
Must have received: endocrine therapy — metastatic
Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
Must have received: chemotherapy — metastatic
Patients with hormone receptor positive disease must have received at least 3 prior endocrine therapies and at least 2 prior lines of chemotherapy in the metastatic setting.
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab, TDM-1) — metastatic
Patients with HER2 positive breast cancer must have received at least 3 prior HER2- directed therapies (trastuzumab, pertuzumab, TDM-1 or others) in the metastatic setting.
Must have received: chemotherapy — metastatic
Patients with triple negative disease must have received at least 2 prior lines of chemotherapy in the metastatic setting.
Cannot have received: investigational agent
Treatment with investigational agent(s) within 30 days of planned lymphodepletion.
Lab requirements
Blood counts
ANC <1000/mm^3; Hemoglobin <9 mg/dl (transfusion permitted); Platelet count <75,000/mm^3
Kidney function
Serum creatinine > 2 mg/dL
Liver function
Bilirubin ≥ 1.5 mg/dL (except Gilbert disease, then >3 mg/dL); AST or ALT ≥ 2.5 x ULN (if hepatic metastases, >3x ULN)
Cardiac function
NYHA class III or IV CHF, clinically significant hypotension, uncontrolled symptomatic CAD, or EF <45%. EF 45-49% requires cardiologist clearance.
Major organ dysfunction defined as: Serum creatinine > 2 mg/dL; Bilirubin ≥ 1.5 mg/dL with the following exception: Patients with known Gilbert disease, serum bilirubin > 3 mg/dL; AST or ALT ≥ 2.5 x upper institutional limit of normal with the following exception: Patients with known hepatic metastases, AST or ALT > 3x upper institutional limit of normal; ...Significant cardiovascular abnormalities as defined by any one of the following: NYHA class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of <45%. Any patient with an EF of 45-49% must receive clearance by a cardiologist to be eligible for the trial.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Medical Center · Duarte, California
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