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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of dose limiting toxicities (DLTs)

Secondary outcome measures

Disease control rate (DCR)

Overall survival (OS)

Progression free survival (PFS)

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 3

~1100

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor

351 Previous Clinical Trials

88,312 Total Patients Enrolled

5 Trials studying Ovarian Cancer

251 Patients Enrolled for Ovarian Cancer

National Institutes of Health (NIH)NIH

2,700 Previous Clinical Trials

7,506,855 Total Patients Enrolled

14 Trials studying Ovarian Cancer

973 Patients Enrolled for Ovarian Cancer

Linda Van Le, MDPrincipal InvestigatorUNC

2 Previous Clinical Trials

38 Total Patients Enrolled

2 Trials studying Ovarian Cancer

38 Patients Enrolled for Ovarian Cancer

Media Library

CAR.B7-H3 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04670068 — Phase 1

Ovarian Cancer Research Study Groups: CAR.B7-H3 T cell product

Ovarian Cancer Clinical Trial 2023: CAR.B7-H3 Highlights & Side Effects. Trial Name: NCT04670068 — Phase 1

CAR.B7-H3 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04670068 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for participants in this clinical trial?

"Affirmative. Data available on clinicaltrials.gov verifies that candidates are being recruited for this medical examination, which was originally posted on January 27th 2021. Last edited on May 27th 2022, the study is hoping to enrol 21 patients from one centre."

Answered by AI

How many participants have been selected to take part in this trial?

"Affirmative. As indicated by the clinicaltrials.gov website, this research programme is presently looking for participants after being initially posted on January 27th 2021 and amended May 27th 2022. 21 patients are required to be recruited from a single centre only."

Answered by AI

What is the current status of CAR.B7-H3's approval by the Food and Drug Administration?

"Our team at Power gave CAR.B7-H3 a rating of 1 as this is merely a Phase 1 study, which implies that there is scant evidence regarding both safety and effectiveness of the drug."

Answered by AI

What other experiments have researchers conducted utilizing CAR.B7-H3?

"Presently, 889 clinical trials are being conducted on CAR.B7-H3 with 161 of those studies in Phase 3. Philadelphia, Pennsylvania is a leading research hub for this medication yet there exist 28443 sites conducting related medical experiments worldwide."

Answered by AI

What is the common application of CAR.B7-H3 in medical treatments?

"CAR.B7-H3 is a viable medical intervention for multiple sclerosis, as well as mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastomas."

Answered by AI

Recent research and studies

Frontiers in Bioscience-LandmarkJournal

CAR-T Cells Targeting Immune Checkpoint Pathway Players

Golubovskaya, Vita. 2022. “CAR-T Cells Targeting Immune Checkpoint Pathway Players”. Frontiers in Bioscience-landmark. IMR Press. doi:10.31083/j.fbl2704121.

clinicaltrials.govStudy

Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian

2021. "Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04670068.