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CAR T-cell Therapy

MUC1-Activated T Cells for Ovarian Cancer

Phase 1

Recruiting

Led By Brenda J. Ernst, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory

Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease

Must not have

Other active malignancy first documented ≤ 4 years prior to registration

Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of using a patient's own T cells that have been modified to recognize a specific protein found on ovarian tumor cells. The goal is to see if these modified T

Who is the study for?

This trial is for patients with ovarian cancer that has returned or resisted treatment. Participants must have a specific protein, MUC1, on their tumor cells. They will undergo various imaging tests and procedures like leukapheresis to prepare T-cells.

What is being tested?

The trial is testing the safety and optimal dosage of lab-made MUC1-activated T cells in treating relapsed/resistant ovarian cancer. These are patient's own immune cells modified to target and kill cancer cells expressing the MUC1 protein.

What are the potential side effects?

Potential side effects may include reactions related to immune cell infusion, such as fever, chills, fatigue; effects from preparatory chemotherapy like nausea; and possible organ inflammation due to targeted immune response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ovarian cancer cells test positive for MUC1.

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I have a confirmed diagnosis of ovarian, fallopian tube, carcinosarcoma, or peritoneal cancer.

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I am 18 years old or older.

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I have been diagnosed with ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer.

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My ovarian cancer has returned or didn't respond to treatment, and I've had platinum-based chemotherapy before.

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I am fully active or can carry out light work.

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I am willing to have a procedure to collect blood components.

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My kidneys are functioning well enough, with a creatinine clearance of at least 30 ml/min.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with another cancer within the last 4 years.

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I still have side effects from my last treatment that haven't improved.

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I do not have any uncontrolled illnesses.

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I need high doses of steroids every day for my condition.

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I have received treatments targeting MUC1.

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I have been diagnosed with plasma cell leukemia.

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I have untreated or ongoing brain metastases.

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I have had a heart attack in the last 6 months or I am being treated for heart failure.

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I am HIV positive and currently on antiretroviral therapy.

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I have been diagnosed with an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicities (DLT)

Maximum tolerated dose (MTD)

Objective response rate

Secondary study objectives

Clinical benefit rate

Incidence of AEs

Overall survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (MUC1-activated T cells, lymphodepletion)Experimental Treatment10 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Multigated Acquisition Scan

2015

Completed Phase 3

~270