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OncoMatch/Clinical Trials/NCT06483048

MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer

Is NCT06483048 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous MUC1-activated T-cells and Bendamustine for platinum-resistant fallopian tube carcinoma.

Phase 1RecruitingMayo ClinicNCT06483048Data as of May 2026

Treatment: Autologous MUC1-activated T-cells · Bendamustine · CyclophosphamideThis phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Biomarker criteria

Required: MUC1 overexpression (IHC staining score > 0)

MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study

Allowed: BRCA1 pathogenic mutation

Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible

Allowed: BRCA2 pathogenic mutation

Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: platinum-based chemotherapy

Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy

Cannot have received: MUC1-targeted therapy

Prior treatment targeting MUC1

Lab requirements

Blood counts

ANC ≥ 1500/mm^3; Lymphocyte count ≥ 1500/mm^3; Hemoglobin ≥ 8.0 g/dL; Platelet count ≥ 30,000/mm^3

Kidney function

Calculated creatinine clearance ≥ 30 ml/min using Cockcroft-Gault formula

Liver function

Total bilirubin ≤ 2.0 mg/dL unless Gilbert's syndrome (≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)

ANC ≥ 1500/mm^3; Lymphocyte count ≥ 1500/mm^3; Hemoglobin ≥ 8.0 g/dL; Platelet count ≥ 30,000/mm^3; Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Calculated creatinine clearance ≥ 30 ml/min using Cockcroft-Gault formula

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic in Arizona · Scottsdale, Arizona

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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