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

ConditionsPlatinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Fallopian Tube CarcinosarcomaRecurrent Female Reproductive System CarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian CarcinosarcomaRecurrent Platinum-Resistant Fallopian Tube CarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Primary Peritoneal CarcinosarcomaRefractory Fallopian Tube CarcinomaRefractory Female Reproductive System CarcinomaRefractory Ovarian CarcinomaRefractory Primary Peritoneal Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Pregnant persons

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous MUC1-activated T-cells

    Biological/Vaccine

    Given IV

  • Bendamustine

    Drug

    Given IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and possible ascites sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT or PET/CT

  • Cyclophosphamide

    Drug

    Given IV

  • Echocardiography

    Procedure/Surgery

    Undergo ECHO

  • Leukapheresis

    Procedure/Surgery

    Undergo leukapheresis

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Multigated Acquisition Scan

    Procedure/Surgery

    Undergo MUGA

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Treatment (MUC1-activated T cells, lymphodepletion)Experimental treatment 10 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Up to 2 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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