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

NCT06483048 | Recruiting Phase 1 DMC FDA Drug

• 4 other identifiers: MC220602HT9425-24-1-0232CDMRP-OC23040124-002437
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This 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.

Conditions

Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Fallopian Tube Carcinosarcoma; Recurrent Female Reproductive System Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Ovarian Carcinosarcoma; Recurrent Platinum-Resistant Fallopian Tube Carcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Primary Peritoneal Carcinosarcoma; Refractory Fallopian Tube Carcinoma; Refractory Female Reproductive System Carcinoma; Refractory Ovarian Carcinoma; Refractory Primary Peritoneal Carcinoma; Platinum-Resistant Fallopian Tube Carcinoma

Outcome Measures

Primary Outcomes (3)

• Dose-limiting toxicities (DLT)

  Adverse events (AEs) will be defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 guidelines. DLT will be defined as an AE if at least possibly related to MUC1-activated T cells.

  Up to 28 days after T cell infusion

• Maximum tolerated dose (MTD)

  MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. MTD will be determined using the Bayesian optimal interval (BOIN) design.

  Up to 28 days after T cell infusion

• Objective response rate

  Tumor response will be based on combined imaging (Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) and tumor markers (CA-125). Objective response rate will be defined as the proportion of patients with an overall best response of complete response (CR) or partial response (PR). Objective response rate will be summarized by descriptive summary statistics. The proportion of patients who achieve an overall as well as specific type of response will be estimated along with corresponding 95% exact binomial confidence intervals.

  Up to 2 years

Secondary Outcomes (7)

• Incidence of AEs

  Up to 2 years

• Toxicity profile

  Up to 2 years

• Clinical benefit rate

  Up to 2 years

• Time to clinical response

  From registration to objective response (overall CR or PR), assessed up to 2 years

• Progression-free survival

  From registration to disease progression or death due to any cause, assessed up to 2 years

Study Arms (1)

Treatment (MUC1-activated T cells, lymphodepletion)

EXPERIMENTAL

Patients undergo leukapheresis over 4 hours within 14 days after registration. Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3 or bendamustine IV over 10 minutes on days -5 and -4 or -4 and -3. Patients receive MUC1-activated T cells IV over 10-60 minutes on day 0 or days 0 and 21. Patients also undergo ECHO or MUGA during screening, and blood sample collection throughout the trial. In addition, patients may undergo CT, MRI, or PET/CT as clinically indicated throughout the trial. Patients may also undergo collection of ascites on study and during follow up.

Biological: Autologous MUC1-activated T-cells; Drug: Bendamustine; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography; Procedure: Leukapheresis; Procedure: Magnetic Resonance Imaging; Procedure: Multigated Acquisition Scan; Procedure: Positron Emission Tomography

Interventions

Autologous MUC1-activated T-cells BIOLOGICAL

Given IV

Also known as: Autologous MUC1-activated T-lymphocytes

Treatment (MUC1-activated T cells, lymphodepletion)

Bendamustine DRUG

Given IV

Also known as: SDX-105

Treatment (MUC1-activated T cells, lymphodepletion)

Biospecimen Collection PROCEDURE

Undergo blood and possible ascites sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (MUC1-activated T cells, lymphodepletion)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (MUC1-activated T cells, lymphodepletion)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719, WR-138719

Treatment (MUC1-activated T cells, lymphodepletion)

Echocardiography PROCEDURE

Undergo ECHO

Also known as: EC

Treatment (MUC1-activated T cells, lymphodepletion)

Leukapheresis PROCEDURE

Undergo leukapheresis

Also known as: Leukocytopheresis, Therapeutic Leukopheresis

Treatment (MUC1-activated T cells, lymphodepletion)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (MUC1-activated T cells, lymphodepletion)

Multigated Acquisition Scan PROCEDURE

Undergo MUGA

Also known as: Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan, MUGA, MUGA Scan, Multi-Gated Acquisition Scan, Radionuclide Ventriculogram Scan, Radionuclide Ventriculography, RNVG, SYMA Scanning, Synchronized Multigated Acquisition Scanning

Treatment (MUC1-activated T cells, lymphodepletion)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (MUC1-activated T cells, lymphodepletion)

Eligibility Criteria

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

You may qualify if:

• PRE-REGISTRATION: Age ≥ 18 years
• PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer
• PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET/CT
• Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler
• PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \< 183 days after the last dose of platinum-based chemotherapy:
• Development of measurable disease (per RECIST 1.1)
• Progression of radiographic disease (per RECIST 1.1)
• Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \[WNL\] at the completion of platinum-based chemotherapy)
• Increase in CA-125 level to ≥ 2 x nadir (if nadir \> ULN)
• If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval
• PRE-REGISTRATION: Provide written informed consent
• PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research
• REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
• REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
• REGISTRATION: 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

You may not qualify if:

• Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \> 30 days, and not requiring steroid therapy for \> 14 days
• Prior treatment targeting MUC1
• Subjects with known plasma cell leukemia (PCL)
• Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential who are unwilling to employ adequate birth control measures
• History of myocardial infarction ≤ 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias
• Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.
• Uncontrolled concurrent illness including, but not limited to:
• Inability to clear an ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Uncontrolled psychiatric problems
• Inability to have a caregiver for active oversight during treatment period

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Bendamustine Hydrochloride; Specimen Handling; Cyclophosphamide; Leukapheresis; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Cytapheresis; Biological Therapy; Therapeutics; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Brenda J. Ernst, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)