CAR.B7-H3 for Carcinoma, Ovarian Epithelial

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Carcinoma, Ovarian Epithelial+4 More
CAR.B7-H3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Carcinoma, Ovarian Epithelial
  • Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: From the date of lymphodepletion to the date of death up to 5 years

Week 4
Incidence of dose limiting toxicities (DLTs)
Month 6
Disease control rate (DCR)
Year 5
Overall survival (OS)
Year 5
Progression free survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

CAR.B7-H3 T cell product
1 of 1

Experimental Treatment

21 Total Participants · 1 Treatment Group

Primary Treatment: CAR.B7-H3 · No Placebo Group · Phase 1

CAR.B7-H3 T cell productExperimental Group · 3 Interventions: Cyclophosphamide, Fludarabine, CAR.B7-H3 · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from the date of lymphodepletion to the date of death up to 5 years

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
311 Previous Clinical Trials
81,772 Total Patients Enrolled
1 Trials studying Carcinoma, Ovarian Epithelial
11 Patients Enrolled for Carcinoma, Ovarian Epithelial
National Institutes of Health (NIH)NIH
2,423 Previous Clinical Trials
24,561,170 Total Patients Enrolled
5 Trials studying Carcinoma, Ovarian Epithelial
110 Patients Enrolled for Carcinoma, Ovarian Epithelial
Paola GehrigPrincipal InvestigatorUNC
Linda Van Le, MDPrincipal InvestigatorUNC
1 Previous Clinical Trials
11 Total Patients Enrolled
1 Trials studying Carcinoma, Ovarian Epithelial
11 Patients Enrolled for Carcinoma, Ovarian Epithelial

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be able to have an intraperitoneal port placed either by vascular interventional radiology or surgically in the operating room.
You have measurable disease per RECIST 1.1 or non-measurable disease (defined as solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.
Subjects must be female, aged 18 years or older, and willing to abstain from heterosexual activity or to use two forms of highly effective methods of contraception from the time of informed consent until 180 days after study treatment discontinuation.
Subjects must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of a high-grade serous histology based on local histopathological findings.
You are included in the study.
You have adequate performance status as defined by ECOG score of ≤ 2.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.