CC-97540 for Lupus

Recruiting at 87 trial locations

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

Age: Any Age

Sex: Any

Trial Phase: Phase 2

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

Must be taking: Glucocorticoids, Immunosuppressants

Must not be taking: Live vaccines, CAR T therapy

Disqualifiers: Cardiovascular, CNS pathology, Malignancies, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 weeks

89 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CC-97540 (NEX-T CAR T Cells) to determine its effectiveness for people with active systemic lupus erythematosus (SLE), including those with lupus-induced kidney inflammation who have not responded well to standard treatments. The trial aims to evaluate the treatment's efficacy and safety. Suitable candidates for this trial have active lupus and have not achieved good results with glucocorticoids and at least two other immunosuppressant drugs. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from a potentially effective new therapy.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires that you have been on glucocorticoids and at least two immunosuppressants for at least 3 months. There might be a washout period for certain treatments like CAR T cell therapy, but it's not clear for other medications.

Is there any evidence suggesting that CC-97540 is likely to be safe for humans?

Research has shown that NEX-T CAR T cells are generally safe. Most side effects, or unintended reactions, occur soon after treatment. In studies, this treatment targeted a specific protein on cells called CD19, which helped reduce certain immune cells and allowed patients to go longer without needing additional treatment.

Patients with severe lupus have tolerated the treatment well, and researchers are studying its effects on the body. While detailed results are still under analysis, early data suggests the treatment is usually well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Researchers are excited about NEX-T CAR T Cells for lupus because they represent a cutting-edge approach by harnessing the power of the body's own immune system. Unlike traditional treatments like corticosteroids and immunosuppressants, which mainly aim to suppress the immune response, NEX-T CAR T Cells are engineered to specifically target and eliminate the problematic immune cells causing the disease. This precision offers the potential for more effective and lasting control of lupus with possibly fewer side effects.

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

Research has shown that NEX-T CAR T cells, which participants in this trial will receive, might help treat systemic lupus erythematosus (SLE), a long-term disease where the immune system attacks the body. In one study, patients with SLE who received CD19 CAR T-cell therapy experienced reduced B-cells and went into remission without needing ongoing treatment. This suggests the therapy could provide lasting relief without continuous medication. Additionally, CAR T cells have shown promise in quickly and effectively putting severe lupus cases into remission. These findings suggest that NEX-T CAR T cells could be a promising treatment option for people with lupus. ^{1 4 6 7 8}

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 active systemic lupus erythematosus (SLE), including those with kidney involvement (lupus nephritis), who haven't gotten better after using steroids and at least two other immune-suppressing drugs.

Inclusion Criteria

I've tried steroids and at least 2 other immune treatments for over 3 months without enough improvement.

I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.

My disease is currently active.

Exclusion Criteria

My organs are functioning properly.

I have not had CAR T cell therapy, genetically modified T cell therapy, or a stem cell transplant.

I haven't had any live vaccines in the last 6 weeks.

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

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NEX-T CAR T Cells

Trial Overview The study tests the effectiveness and safety of CC-97540, a new CAR T cell therapy targeting CD19. Participants will also receive Fludarabine and Cyclophosphamide to prepare their bodies for the treatment.

How Is the Trial Designed?

Group I: Administration of CC-97540 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

19

Recruited

3,100+

Citations

1. 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 Positive, early results from 71 patients treated across three disease cohorts – systemic sclerosis, systemic lupus erythematosus and ...

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 ...

3. ashpublications.org 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 ... In a cohort of patients (pts) with SLE, CD19 CAR T-cell therapy resulted in B-cell depletion and treatment-free, durable remission per ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1297319X24000137

CAR-T cells for treating systemic lupus erythematosus CAR-T cells show rapid and prolonged remission in severe lupus patients. CAR-T cells may offer a steroid-free alternative in several autoimmune diseases.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506445/

Key considerations for advancing chimeric antigen receptor ... Chimeric antigen receptor (CAR) T-cell therapy has shown promise in treating autoimmune diseases, including systemic lupus erythematosus (SLE).

6. 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 ...

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

P105 NEX-T CD19 chimeric antigen receptor (CAR) T-cell ... Here, we present preclinical and phase 1 clinical data demonstrating CD19-specific cell targeting, CC-97540 CAR T expansion, and ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20587442

A Study Of CC-97540 (BMS-986353), CD19-Targeted NEX ... The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus ...