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OVSTAR: Modified vs Unmodified TILs in Platinum-Resistant Ovarian Cancer

NCT04389229Phase 2

Key facts

Status: Withdrawn
Start: Jul 2020
Primary completion: Mar 2023
Countries: 1
Modality: Gene Editing, Gene Silencing, Cell Therapies

Drugs: UTIL-01CoTIL-01
Conditions: ovarian cancer

Overview

Phase 2, open-label trial of UTIL-01 and CoTIL-01 in ovarian cancer (2 cohorts). Primary endpoints: Disease objective response according to RECIST 1.1 at 24 months, Feasibility of treatment assessed by successful completion of planned treatment and 1 more. Planned start Jul 2020; status: withdrawn.

Design

2 arms

Study design: Non-randomizedOpen-label

UTIL-01 Cohort
Unmodified TILs + Lymphodepletion + IL-2
CoTIL-01 Cohort
Gene-modified (CoStAR) TILs + Lymphodepletion + IL-2

Endpoints

Primary

Disease objective response according to RECIST 1.124 months
Feasibility of treatment assessed by successful completion of planned treatment5 days post treatment
Tolerability and safety assessed according to NCI CTCAE v5.0 gradingup to 24 months

Secondary

Percentage change in CA125 according to the Gynaecologic Cancer InterGroup CA125 response definitionup to 24 months
Progression free survivalup to 24 months
Duration of overall response and stable diseaseup to 24 months

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