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NCT04630769 · ClinicalTrials.gov registry record · Phase 1

FT516 and IL2 With Enoblituzumab for Ovarian Cancer

A Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer, sponsored by Masonic Cancer Center, University of Minnesota.

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT04630769 is a Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04630769, a Phase 1 study of Ovarian Cancer and Primary Peritoneal Cavity Cancer, has completed, sponsored by Masonic Cancer Center, University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

This is a single center Phase I clinical trial of FT516 administered intraperitoneally (IP) once a week for 3 consecutive weeks for the treatment of recurrent gynecologic cancers. As this is an early 1st in human study and the 1st intraperitoneal infusion of FT516, the safety of FT516 is confirmed prior to adding enoblituzumab as an intravenous infusion approximately 1 week prior to the 1st dose of FT516 and every 3 weeks beginning on Day 22 (1 week after the last dose of FT516). Each dose of FT516 is followed directly by an IP infusion of interleukin-2 (IL-2) to facilitate natural killer (NK) cell survival. A short course of outpatient lymphodepletion chemotherapy is given prior to the 1st dose of FT516.

Interventions

  • DRUG Enoblituzumab
  • DRUG IL-2
  • DRUG IP FT516

Study Locations (1)

Minnesota

  • University of Minnesota, Masonic Cancer Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-04-02
Est. Completion 2022-01-01
Phase Phase 1

What the Registry Record Tells You About NCT04630769

The ClinicalTrials.gov registry entry for NCT04630769 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Enoblituzumab is the first listed.

NCT04630769 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT04630769 about?

NCT04630769 is a clinical study titled "FT516 and IL2 With Enoblituzumab for Ovarian Cancer". This is a single center Phase I clinical trial of FT516 administered intraperitoneally (IP) once a week for 3 consecutive weeks for the treatment of recurrent gynecologic cancers. As this is an early 1st in human study and the 1st intraperitoneal infusion of FT516, the safety of FT516 is confirmed p...

What is the current status of trial NCT04630769?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-04-02. Estimated completion is 2022-01-01.

What conditions does trial NCT04630769 study?

This clinical trial studies the following conditions: Ovarian Cancer, Primary Peritoneal Cavity Cancer, Fallopian Tube Adenocarcinoma.

What interventions are being tested in trial NCT04630769?

The interventions under investigation include: Enoblituzumab (DRUG), IL-2 (DRUG), IP FT516 (DRUG).

Who is sponsoring clinical trial NCT04630769?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04630769 being conducted?

This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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