CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 4 enrolled
Drug / intervention
CAR.B7-H3 +2 moredrug
Likely dose
Fludarabine 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04670068
NCT04670068Phase 1Active
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A Phase 1 Study of Autologous Activated T-cells Targeting the B7-H3 Antigen in Subjects With Recurrent Epithelial Ovarian Cancer

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Dec 17, 2020·Updated Dec 22, 2025

In Brief

A Phase 1 clinical trial evaluating CAR.B7-H3, Fludarabine, and 1 other intervention for Epithelial Ovarian Cancer. Active but no longer recruiting, targeting 4 participants across 1 site.

Detailed Summary

This is single center, open-label phase 1 dose escalation trial that uses 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpithelial Ovarian Cancer
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 1Active
2021202220232024202520262027202820292030
First PostedDec 17, 2020
Enrollment StartJan 27, 2021
Primary CompletionDec 19, 2024
Study CompletionFeb 1, 2030
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 5.5 years ago

Interventions

CAR.B7-H3drug

Two dose levels will be evaluated: Dose Level 1 (7.5x10\^7 cells/infusion), dose Level 2 (2x10\^8 cells/infusion). If dose limiting toxicities (DLTs) are observed per protocol, Dose Level -1 (3.75x10\^6 cells/infusion) will be evaluated.

Fludarabinedrug

30 mg/m\^2 IV for 3 consecutive days

Cyclophosphamidedrug

300 mg/m\^2 IV for 3 consecutive days