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CAR T-cell Therapy

CAR T-Cell Therapy for Ovarian Cancer

Phase 1

Recruiting

Led By Linda Van Le, MD

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Older than 18 years at the time of consent

Have failed prior therapy with a PARP inhibitor if the subject has a germline or somatic BRCA mutation

Must not have

Subject has a history of gastrointestinal perforation

Subject has intraparenchymal lung metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of lymphodepletion to the date of death up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is using a modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.

Who is the study for?

This trial is for adults over 18 with recurrent ovarian cancer that's resistant to platinum-based chemotherapy and PARP inhibitors if they have BRCA mutations. Participants must be in good enough health to undergo procedures, agree to use two forms of contraception, and not be pregnant or breastfeeding. They can't join if they have certain other cancers, brain metastases, active infections like HIV or hepatitis, or recent bowel complications.

What is being tested?

The study tests CAR T-cells targeting B7-H3 antigen in patients with ovarian cancer using a '3+3 design' to find the safest dose for phase 2 trials. Up to 21 people will receive this treatment after being screened for eligibility. The process includes placing an intraperitoneal port and multiple biopsies before and after treatment.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever, fatigue, infusion-related symptoms; organ inflammation; blood count changes; increased risk of infection due to immune system suppression from Fludarabine and Cyclophosphamide used during cell preparation.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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I have a BRCA mutation and previous treatments with PARP inhibitors did not work for me.

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I can have a port placed in my abdomen for treatment.

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My recent tests show my organs are functioning well and confirm my disease is active.

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My disease can be measured or observed.

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I can take care of myself and perform daily activities.

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My cancer did not respond to platinum-based chemotherapy.

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I have high-grade serous ovarian, peritoneal, or fallopian tube cancer.

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I have undergone at least 2 previous treatment cycles.

Exclusion Criteria

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

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I have had a gastrointestinal perforation in the past.

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My cancer has spread to the tissue of my lungs.

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I rely on IV fluids or nutrition through a vein.

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I have had symptoms of diverticular disease confirmed by a CT scan or colonoscopy.

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I have another cancer that is growing and needs treatment.

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I am currently taking 10 mg or more of prednisone daily or its equivalent.

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My cancer has spread to my brain.

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I have an active infection with HIV, HTLV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of lymphodepletion to the date of death up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of lymphodepletion to the date of death up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of lymphodepletion to the date of death up to 5 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

Incidence of dose limiting toxicities (DLTs)

Secondary study objectives

Disease control rate (DCR)

Overall survival (OS)

Progression free survival (PFS)

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: CAR.B7-H3 T cell productExperimental Treatment3 Interventions

Up to 12 patients will receive three weekly CAR.B7-H3 T cell product infusions at the same dose. To determine the recommended phase 2 dose (RP2D), a modified 3+3 dose escalation design will be used to evaluate two dose levels: Dose Level 1 (7.5x10\^7 cells/infusion), Dose Level 2 (2x10\^8 cells/infusion). If this dose is not tolerated, then a lower dose of 3.75 × 10\^6 cells/infusion will be explored. Up to 3 dose levels of CAR.B7-H3 cells will be tested with at least 3 patients enrolled at each dose cohort before dose escalation is considered based on the incidence of dose limiting toxicity (DLT). An expansion cohort will enroll up to 9 patients at the recommended phase 2 dose. Prior to receiving the infusions, patients will undergo lymphodepletion with fludarabine and cyclophosphamide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310