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Platinum-Resistant Fallopian Tube CarcinomaPhase 1NCT06483048

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

A Phase 1 study testing Autologous MUC1-activated T-cells, Bendamustine and Biospecimen Collection in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Autologous MUC1-activated T-cells, Bendamustine and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
20 Sep 2024to 30 Sep 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months
  • REGISTRATION: Willingness and ability to provide written informed consent
  • REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study
  • REGISTRATION: Willing to undergo leukapheresis for blood component collection
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)
  • REGISTRATION: Lymphocyte count ≥ 1500/mm^3 (performed ≤ 14 days prior to registration)
  • REGISTRATION: Hemoglobin ≥ 8.0 g/dL (performed ≤ 14 days prior to registration)
  • REGISTRATION: Platelet count ≥ 30,000/mm^3 (performed ≤ 14 days prior to registration)
  • REGISTRATION: Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)
  • Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)
  • REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis [DVT]/pulmonary embolism [PE] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)
  • REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)
  • REGISTRATION: Baseline oxygen saturation ≥ 90% on room air
  • REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration

Who cannot join

  • 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
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  • 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
  • Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
  • Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements
  • Evidence of clinical immunocompromise and/or HIV positivity and currently receiving antiretroviral therapy
  • Patients requiring chronic supraphysiologic daily doses of steroids (> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)
  • Patients receiving any other investigational agent which could be considered a treatment for the neoplasm
  • Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence
  • Diagnosis of autoimmune disease
  • Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Brenda J. Ernst, MD

    Recruiting

Other trials in United States

About this study

Official title: Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the maximum tolerated dose (MTD) of autologous MUC1-activated T-cells (in-house, manufactured MUC1-activated T cells) in patients with relapsed/refractory MUC1-expressing ovarian cancer.

SECONDARY OBJECTIVES:

  1. Obtain preliminary efficacy associated with MUC1-targeting peripheral blood mononuclear cells (PBMC)-derived T cells in conjunction with cyclophosphamide (CTX) in MUC1-expressing ovarian cancer patients as measured by objective response rate (best overall response of either partial response [PR] or complete response [CR]), duration of response, clinical benefit rate (CR, PR or stable disease [SD]), time to disease progression, progression free survival (PFS), and overall survival (OS).

II. Determine feasibility of in-house production and administration of MUC1-targeting PBMC-derived T cells and ability to proceed with T cell dose escalation.

III. Evaluate the safety profile of in-house, manufactured MUC1-activated T cells in patients with relapsed/refractory MUC1-expressing ovarian cancer, including all grades of neurotoxicity (immune effector cell associated neurotoxicity [ICANS]) and cytokine release syndrome (CRS) as determined by American Society for Transplantation and Cellular Therapy (ASTCT) criteria (Lee 2018).

IV. Evaluate the preliminary efficacy of MUC1 T cells in patients that have received bridging therapy compared to those that did not receive bridging therapy.

CORRELATIVE OBJECTIVES:

  1. Determine whether culture expansion generated T cell receptor (TCR) oligoclonality through TCR Vbeta Analyses; whether such T cells persist in the circulation following adoptive transfer; and whether such persistence significantly correlates to objective responses.

II. Determine whether MUC1-activated T cells results in systemic inflammatory signaling by characterizing the changes in serum cytokine levels over time.

III. Determine whether T cells recognizing MUC1 in an MHC-restricted manner in culture (intracellular IFN-γ assays, enzyme-linked immunosorbent spot assay [ELISpot]) correspond to therapeutic efficacy upon subsequent adoptive transfer.

IV. Determine the immunophenotype of the pre-infusion cell product (day 0 and day 19), assessing cellular differentiation, activation, effector molecules, and exhaustion markers, and assess whether any parameters correlate with objective responses.

  1. Determine the cytokine production at a single-cell level of the pre-infusion cell product (day 0 and day 19).

VI. Evaluate the immunophenotype of diagnostic tumor material, post-T cell infusion biopsy material, post-relapse tumor material, and ascites (when available).

VII. Determine whether MUC1-activated T cell infusion is associated with changes in peripheral blood immune cell subsets.

VIII. Assess hospital resource utilization and health economics. VIIIa. Total number of hospitalizations, intensive care unit (ICU) admissions and length of stay in hospital and ICU, time between cell collection and infusion, and total cost of product.

OUTLINE: This is a dose-escalation study.

Patients undergo leukapheresis over 4 hours within 14 days after registration. Patients receive cyclophosphamide intravenously (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 echocardiography (ECHO) or multigated acquisition scan (MUGA) during screening, and blood sample collection throughout the trial. In addition, patients may undergo computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)/CT as clinically indicated throughout the trial. Patients may also undergo collection of ascites on study and during follow up.

Patients are followed up at 30 and 60 days from day 28, then every 3 months for 2 years.

Being tested
Autologous MUC1-activated T-cells, Bendamustine, Biospecimen Collection, Computed Tomography, Cyclophosphamide
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous MUC1-activated T-cellsBiological

    Also called Autologous MUC1-activated T-lymphocytes

    Given IV

  • BendamustineDrug

    Also called SDX-105

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood and possible ascites sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B-518

    Given IV

  • EchocardiographyProcedure or surgery

    Also called EC

    Undergo ECHO

  • LeukapheresisProcedure or surgery

    Also called Leukocytopheresis, Therapeutic Leukopheresis

    Undergo leukapheresis

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT06483048
Study groupRoleWhat they receive
Treatment (MUC1-activated T cells, lymphodepletion)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 28 days after T cell infusion

  2. 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.

    Measured: Up to 28 days after T cell infusion

  3. 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.

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Incidence of AEs

    AEs will be defined per CTCAE v 5.0 guidelines. CRS and neurotoxicity will be graded using ASTCT criteria. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns by dose level and overall. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with corresponding 95% exact binomial confidence intervals.

    Measured: Up to 2 years

  2. Toxicity profile

    Toxicities will be defined per CTCAE v5 as adverse events considered to be at least possibly related to study treatment. Overall toxicity incidence will be as well as toxicity profiles by dose level will be summarized.

    Measured: Up to 2 years

  3. Clinical benefit rate

    Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Clinical benefit rate will be defined as the proportion of patients with an overall best response of CR, PR or stable disease. Clinical benefit 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.

    Measured: Up to 2 years

  4. Time to clinical response

    Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Will be estimated using the method of Kaplan-Meier.

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

  5. Progression-free survival

    Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). The distribution of survival time will be estimated using the method of Kaplan-Meier (overall and by dose level).

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

  6. Time to progression

    Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Time to progression will be estimated using the method of Kaplan-Meier (overall and by dose level).

    Measured: From registration to disease progression, assessed up to 2 years

  7. Overall survival

    Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). The distribution of overall survival will be estimated using the method of Kaplan-Meier (overall and by dose level).

    Measured: From registration to death due to any cause, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start20 Sep 2024
  3. Primary completion30 Sep 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06483048
Sponsor's protocol ID
MC220602
Other IDs
HT9425-24-1-0232, CDMRP-OC230401, 24-002437
Status last verified
Mar 2026
First submitted
25 Jun 2024
Last updated
16 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous MUC1-activated T-cells, Bendamustine and Biospecimen Collection in people with Platinum-Resistant Fallopian Tube Carcinoma and Platinum-Resistant Ovarian Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLT) (time frame: Up to 28 days after T cell infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06483048.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.

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