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 (Jun 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
Treatments studied
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04020575 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior investigational agent disqualifies patients from enrollment.
Does this trial require MUC1?
Yes, MUC1 cleaved form (MUC1*) membrane expression ≥30% is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages