CC-97540 for Severe Refractory Lupus

Recruiting at 86 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Drug-induced SLE, Multiple sclerosis, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new drug, CC-97540, for individuals with severe autoimmune diseases unresponsive to other treatments. It targets conditions such as lupus, inflammatory muscle diseases, systemic sclerosis (a connective tissue disease), and rheumatoid arthritis. Participants should have struggled with these conditions despite trying multiple treatments. The study will also compare the effects of two other drugs, cyclophosphamide and fludarabine. Individuals with these conditions whose current treatments aren't effective might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants must have had an inadequate response to certain treatments, which suggests that you may continue some existing medications. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that CC-97540 is being tested for safety and tolerability. In a study with 71 patients, researchers examined this treatment for severe autoimmune diseases, such as lupus.

As a Phase 1 trial, this stage is early in the testing process. The main goal is to determine if CC-97540 is safe for humans. Early results from similar studies indicate that researchers closely monitor patient reactions to the treatment. They check for harmful side effects and assess overall patient tolerance.

At this stage, scientists are beginning to gather safety information. So far, they are diligently working to understand how CC-97540 affects individuals with severe conditions. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for severe refractory lupus, which often include immunosuppressive drugs like corticosteroids and methotrexate, CC-97540 offers a novel approach. Researchers are excited because CC-97540 targets specific pathways involved in the immune response, potentially offering a more precise treatment with fewer side effects. This treatment could provide hope for patients who don't respond well to existing therapies, as it aims to modulate the immune system in a way that is different and potentially more effective than current options.

What evidence suggests that CC-97540 might be an effective treatment for severe refractory lupus?

Research has shown that CC-97540, a new treatment under study in this trial, may benefit people with severe, hard-to-treat autoimmune diseases like lupus. In studies, patients receiving this treatment showed promising results, with some experiencing symptom improvements. CC-97540 targets a specific protein on certain immune cells, similar to a method used in an FDA-approved treatment for related conditions. Early findings suggest that this therapy is generally safe and might help manage challenging cases of lupus. Although more research is needed, the initial results offer hope for those facing severe forms of the disease. ^{4 6 7 8 9}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My lupus affects specific organs and hasn't improved with several treatments.

I have been diagnosed with IIM according to the 2017 criteria.

I have antibodies linked to autoimmune conditions.

Exclusion Criteria

My inflammatory muscle disease is not active.

Other systemic autoimmune diseases excluding specific conditions

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CC-97540, CD19-Targeted Nex-T CAR T Cells

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CC-97540
• Cyclophosphamide
• Fludarabine

Trial Overview

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.

How Is the Trial Designed?

Group I: Administration of CC-97540 Experimental Treatment 4 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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

Lead Sponsor

Trials

19

Recruited

3,100+

Bristol-Myers Squibb Services Unlimited Company

Collaborator

Trials

1

Recruited

130+

Published Research Related to This Trial

Mycophenolate mofetil (Cellcept) has been shown to be effective for both induction and maintenance therapy in lupus proliferative glomerulonephritis, with fewer adverse events compared to traditional treatments like monthly intravenous cyclophosphamide.

Rituximab (Rituxan) is a promising biologic therapy for severe systemic lupus erythematosus, targeting B-cells, although its use is currently limited and requires further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel approaches to therapy for systemic lupus erythematosus: update 2005. Zandman-Goddard, G., Orbach, H., Shoenfeld, Y.[2010]

In a study using BXSB mice, a model for systemic lupus erythematosus (SLE), treatment with fludarabine resulted in a significant reduction in kidney damage compared to control treatments, suggesting its potential efficacy in managing SLE-related renal pathology.

Fludarabine treatment also led to a notable increase in specific immune cell populations (CD8+CD25+ and CD4+CD25+ T cells), indicating a possible mechanism of action that could enhance immune regulation in SLE, although further research in humans is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of fludarabine treatment on murine lupus nephritis. Jones, OY., Alexander, PJ., Lacson, A., et al.[2023]

Cyclophosphamide (CY) combined with methyl-prednisolone (MP) is the gold standard treatment for severe lupus nephritis, significantly improving patient prognosis based on randomized controlled trials and long-term studies.

Newer immunosuppressive agents like mycophenolate mofetil (MMF) have shown comparable efficacy to CY with less gonadal toxicity, making them suitable alternatives for moderately severe lupus, while azathioprine and MMF are effective for maintenance therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cyclophosphamide and lupus nephritis: when, how, for how long? Ntali, S., Bertsias, G., Boumpas, DT.[2021]

Intravenous cyclophosphamide is now the standard treatment for severe systemic lupus erythematosus, especially for cases involving major organs like the kidneys (lupus nephritis).

Newer cytotoxic drugs, such as cyclosporin A and mycophenolate mofetil, show promise in improving lupus management, particularly for patients with less severe forms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indications for, and use of, cytotoxic agents in SLE. Klippel, JH.[2019]

A short course of low-dose fludarabine combined with cyclophosphamide can lead to significant improvements in patients with active proliferative lupus nephritis, with 10 out of 11 evaluated patients showing marked improvement and 7 achieving complete remission.

However, the treatment was associated with severe bone marrow toxicity, including profound lymphocytopenia and serious adverse events, which limits its safety and widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of combination treatment with fludarabine and low-dose pulse cyclophosphamide in patients with lupus nephritis. Illei, GG., Yarboro, CH., Kuroiwa, T., et al.[2013]

High-dose corticosteroids are the standard initial treatment for severe inflammation in lupus nephritis, but long-term management often requires additional therapies to address underlying immune system issues.

New treatment options for lupus nephritis include novel immunosuppressive agents and combination therapies, which may improve efficacy and reduce toxicity compared to traditional treatments like cyclophosphamide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in the treatment of proliferative lupus nephritis. Balow, JE., Austin, HA.[2019]

High-dose cyclophosphamide (200 mg/kg) can lead to significant reductions in disease activity in patients with severe systemic lupus erythematosus (SLE), as shown by a decrease in average scores from the Systemic Lupus Activity Measure-2 and SLE Disease Activity Index after treatment.

Despite all four patients experiencing febrile neutropenia, there were no long-term complications or deaths, suggesting that high-dose cyclophosphamide may be a safe and effective option for treating severe SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose cyclophosphamide for severe systemic lupus erythematosus. Gladstone, DE., Prestrud, AA., Pradhan, A., et al.[2017]

Citations

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news.bms.com

news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Encouraging-Data-from-Phase-1-Breakfree-1-Study-of-CD19-NEX-T-CAR-T-Cell-Therapy-in-Three-Chronic-Autoimmune-Diseases-at-ACR-Convergence-2025/default.aspx

Corporate news details

... CD19-targeted NEX-T™ CAR T cell therapy BMS-986353 (CC-97540). The data, evaluating a total of 71 treated patients across the systemic ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05869955

NCT05869955 | A Study of CC-97540, CD-19-Targeted ...

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

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ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/2088/529040/Tolerability-Efficacy-Pharmacokinetics-and

Tolerability, Efficacy, Pharmacokinetics, and ...

BMS-986353 (CC-97540) is an investigational CAR T cell therapy expressing the CD19-targeting CAR used in FDA-approved lisocabtagene maraleucel (liso-cel).

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006497124048353

Tolerability, Efficacy, Pharmacokinetics, and ...

Here, we report updated data on BMS-986353 in severe, refractory autoimmune diseases. ... BMS-986353, a NEX-T investigational CD19-targeted CAR T cell ...

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acrabstracts.org

acrabstracts.org/abstract/updated-phase-1-trial-data-assessing-the-tolerability-efficacy-pharmacokinetics-and-pharmacodynamics-of-bms-986353-cc-97540-a-cd19-directed-chimeric-antigen-receptor-t-cell-therapy-using-a-next/

Updated Phase 1 Trial Data Assessing the Tolerability, ...

Updated Phase 1 Trial Data Assessing the Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of BMS-986353 (CC-97540), a CD19-directed Chimeric ...

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lupus.bmj.com

lupus.bmj.com/content/11/Suppl_1/A115

P105 NEX-T CD19 chimeric antigen receptor (CAR) T-cell ...

CC-97540 is being tested in the phase 1, multicenter, open-label study evaluating the safety and tolerability in patients with severe, ...

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mountsinai.org

mountsinai.org/clinical-trials/study-of-cc-97540-in-participants-with-severe-refractory-systemic-lupus-erythematosus-sle

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells ...

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

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05869955

NCT05869955 | A Study of CC-97540, CD-19-Targeted ...

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

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ashpublications.org/blood/article/142/Supplement%201/6873/505648/Nex-T-TM-Cluster-of-Differentiation-19-CD19

Nex-T TM Cluster of Differentiation 19 (CD19) Chimeric ...

The ongoing phase 1, multicenter, open-label study will evaluate the safety, feasibility, and preliminary efficacy of BMS-986353 (CC-97540) in ...