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.
- Carcinoma, Ovarian Epithelial
- Carcinoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: From the date of lymphodepletion to the date of death up to 5 years
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:About The Reviewer
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.
- Golubovskaya, Vita. 2022. “CAR-T Cells Targeting Immune Checkpoint Pathway Players”. Frontiers in Bioscience-landmark. IMR Press. doi:10.31083/j.fbl2704121.
- Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.
- 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.