← Back to Search

Other

CC-97540 for Severe Refractory Lupus

Phase 1

Recruiting

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years after cc-97540 infusion

Awards & highlights

Study Summary

This trial tests a new drug to see if it can help people with severe Lupus that hasn't responded to other treatments.

Who is the study for?

This trial is for people with severe, hard-to-treat Systemic Lupus Erythematosus (SLE). Participants must meet specific SLE criteria and have active disease in major organs. They should have tried at least two treatments like cyclophosphamide or mycophenolic acid without success.Check my eligibility

What is being tested?

The study tests the safety, initial effectiveness, and how the body processes CC-97540 in participants with tough SLE cases. It also involves pre-treatment drugs Fludarabine and Cyclophosphamide to prepare the immune system.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased infection risk, possible negative effects on bone marrow function leading to blood disorders, nausea, hair loss from chemotherapy agents.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years after cc-97540 infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years after cc-97540 infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years after cc-97540 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with AEs of special interest (AESI) in each indication.

Number of participants with Dose Limiting Toxicities (DLT) in each indication.

Number of participants with laboratory abnormalities in each indication.

+3 more

Secondary outcome measures

Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))

Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)

Change in proteinuria measured by urine protein creatinine ratio (UPCR)

+10 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Administration of CC-97540Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,641 Previous Clinical Trials

4,129,935 Total Patients Enrolled

5 Trials studying Lupus

1,111 Patients Enrolled for Lupus

Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyLead Sponsor

14 Previous Clinical Trials

1,598 Total Patients Enrolled

Bristol-Myers Squibb Services Unlimited CompanyUNKNOWN

Media Library

CC-97540 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05869955 — Phase 1

Lupus Research Study Groups: Administration of CC-97540

Lupus Clinical Trial 2023: CC-97540 Highlights & Side Effects. Trial Name: NCT05869955 — Phase 1

CC-97540 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869955 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What difficulties can arise from the implementation of CC-97540 treatments?

"Since this is just a Phase 1 trial, the safety score of Administration of CC-97540 was assessed to be 1 due to limited data that has been collected on its efficacy and security."

Answered by AI

Are there any opportunities to join this investigation currently available?

"The information hosted on clinicaltrials.gov suggests this medical trial is not presently seeking candidates. It was initially posted to the website July 15th 2023 and edited most recently June 27th, 2023. However, there are 141 other trials actively looking for participants at present."

Answered by AI

How widely dispersed are the locations administering this clinical trial throughout the state?

"The current locations for this medical trial are Mayo Clinic in Jacksonville, Florida; Mayo Clinic in Rochester, Minnesota; Washington University School of Medicine in Saint Louis, Missouri and 12 other clinical sites."

Answered by AI