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CAR T-cell Therapy

CAR T Cell Therapy for Ovarian and Peritoneal Cancer

Phase 1

Waitlist Available

Led By Payal D Shah, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

No concurrent treatment for the CNS disease.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Must not have

HIV infection.

Patients with active and uncontrolled infection.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of cancer treatment involving genetically modified immune cells.

Who is the study for?

This trial is for adults with advanced stage high grade serous ovarian, fallopian tube, or primary peritoneal cancer that has returned after treatment. Participants must have measurable disease and express a specific protein on their tumors. They should be in good physical condition with proper organ function and not have active infections or other cancers.

What is being tested?

The study tests MOv19-BBz CAR T cells given through the abdomen to see if they're safe and work against ovarian-type cancers expressing a certain protein. Some patients may also receive chemotherapy drugs cyclophosphamide + fludarabine before the CAR T cells to prepare their bodies.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever, fatigue, changes in blood pressure, difficulty breathing, and organ inflammation. Chemotherapy can cause nausea, hair loss, mouth sores, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am not receiving any treatment for brain or spinal cord disease.

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I am fully active or can carry out light work.

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My cancer is a high-grade serous type in the ovary, fallopian tube, or peritoneum and can be treated with platinum-based therapy or not.

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I have tried at least two chemotherapy treatments for my advanced disease without success.

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I do not have cancer spread to the lining of my brain or spinal cord.

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My tumor shows high levels of aFR.

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I am 18 years old or older.

Exclusion Criteria

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

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I am HIV positive.

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I do not have any active or uncontrolled infections.

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I am scheduled to receive high dose corticosteroids.

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I am taking strong medication for an autoimmune disease.

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My cancer is a high-grade serous type and does not respond to platinum-based treatments.

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I have an active cancer that is not ovarian cancer.

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I do not have symptoms from cancer spread to my brain.

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I have hepatitis B or C.

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I have had fluid drained from my abdomen within the last 4 weeks.

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I have previously received treatment with lentiviral gene modified cells.

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I need extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort-1: without chemo;only if dose de-escalation requiredExperimental Treatment2 Interventions

Cohort -1: (n= 3 to 6 subjects): Single Infusion of 1-3x106 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy. Up to 6 subjects will be infused in Cohort -1 with ≤ 1 DLT/6 subjects to establish the MTD.

Group II: Cohort 3: MOv19-BBz CAR T cells after chemoExperimental Treatment2 Interventions

Cohort 3: (n=3 to 6 subjects): Single infusion of 1-3x108 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group III: Cohort 2: MOv19-BBz CAR T cells after chemoExperimental Treatment2 Interventions

Cohort 2: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 beginning 3 days (+/- 1 day) after lymphodepleting chemotherapy with cyclophosphamide + fludarabine.

Group IV: Cohort 1: MOv19-BBz CAR T cells without chemoExperimental Treatment2 Interventions

Cohort 1: (n= 3 to 6 subjects): Single infusion of 1-3x107 /m2 lentivirally transduced MOv19-BBz CAR T cells on day 0 without lymphodepleting chemotherapy.

0 / 18Eligibility criteria met