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NCT05869955 · ClinicalTrials.gov registry record · Phase 1

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

A Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

Recruiting
Registry status
Phase 1
Development phase
270
Enrollment target
20
Study locations

NCT05869955 is a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus that is actively recruiting participants, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. The registered enrollment target is 270 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT05869955, a Phase 1 study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, is actively recruiting participants, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

RECRUITING
Registry status
Phase 1
Development phase
270 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Conditions Studied

Rheumatoid Arthritis Systemic Lupus Erythematosus Systemic Sclerosis Idiopathic Inflammatory Myopathy

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Tocilizumab
  • DRUG CC-97540

Study Locations (20)

Massachusetts

  • Local Institution - 0038 - Boston
  • Local Institution - 0046 - Boston
  • University of Massachusetts Chan Medical School - Worcester
  • University of Massachusetts Chan Medical School - Worcester

New York

  • NYU Langone Health - New York
  • Local Institution - 0054 - New York
  • Icahn School of Medicine at Mount Sinai - New York

Colorado

  • University of Colorado Anschutz Medical Campus - Aurora
  • Colorado Blood Cancer Institute - Denver

Florida

  • Mayo Clinic in Florida - Jacksonville
  • University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami

Michigan

  • University of Michigan - Ann Arbor
  • Henry Ford Medical Center - New Center One - Detroit

Connecticut

  • Local Institution - 0048 - New Haven

Illinois

  • Local Institution - 0053 - Chicago

Maryland

  • Local Institution - 0030 - Baltimore

Trial Details

FieldValue
Enrollment Target 270 participants
Start Date 2023-09-13
Est. Completion 2028-08-29
Phase Phase 1

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

14 total trials

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What the Registry Record Tells You About NCT05869955

The ClinicalTrials.gov registry entry for NCT05869955 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower). The listed sponsor is Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 14 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.

NCT05869955 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Massachusetts, New York, Colorado.

Frequently Asked Questions

What is clinical trial NCT05869955 about?

NCT05869955 is a clinical study titled "A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)". The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

What is the current status of trial NCT05869955?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 270 participants. The study started on 2023-09-13. Estimated completion is 2028-08-29.

What conditions does trial NCT05869955 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopathic Inflammatory Myopathy.

What interventions are being tested in trial NCT05869955?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tocilizumab (DRUG), CC-97540 (DRUG).

Who is sponsoring clinical trial NCT05869955?

This trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 14 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05869955 being conducted?

This trial has 20 study locations across Colorado, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.