CC-97540 for Vasculitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called CC-97540, an experimental therapy, to determine its safety for people with a severe type of vasculitis, where blood vessels become inflamed. It specifically targets those who have either relapsed, with symptoms returning after treatment, or have a form that doesn't respond to standard treatments like certain medications. Before receiving CC-97540, participants will undergo special chemotherapy to prepare the body for the new treatment. Individuals dealing with active vasculitis despite previous treatments may be a good fit 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 therapy.
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 standard treatments like rituximab or cyclophosphamide for severe disease and methotrexate or azathioprine for non-severe disease are part of the standard care. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that CC-97540 can be safe for people with serious health conditions. In early trials, patients taking small doses of CC-97540 demonstrated encouraging safety results. The treatment also increased the number of CAR T cells, which are part of the immune system. However, more information about long-term safety is needed, and research continues to explore any possible side effects. Prospective trial participants should consult a healthcare provider to understand how these findings might relate to them.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for vasculitis, which often include corticosteroids and immunosuppressive drugs like methotrexate or azathioprine, CC-97540 introduces a novel approach by being administered after lymphodepleting chemotherapy. This treatment is unique because it combines cyclophosphamide and fludarabine to prepare the immune system, paving the way for CC-97540 to be more effective. Furthermore, CC-97540 is delivered intravenously in a single infusion, which could simplify the treatment regimen and potentially enhance patient compliance. Researchers are excited about CC-97540 because it targets the immune system differently, with the hope of improving efficacy and reducing long-term side effects associated with conventional therapies.
What evidence suggests that CC-97540 might be an effective treatment for vasculitis?
Research has shown that CC-97540, a type of CAR-T cell therapy, holds promise in early studies for treating autoimmune diseases. CAR-T cell therapy uses specially modified immune cells to find and destroy harmful cells in the body. Initial results suggest that CC-97540 can significantly improve conditions like systemic lupus erythematosus (SLE), with patients experiencing noticeable reductions in disease symptoms. In this trial, participants will receive CC-97540 following lymphodepleting chemotherapy. Although data collection on its effectiveness for ANCA-associated vasculitis continues, these early findings are encouraging. This treatment's ability to target specific immune cells offers hope for those with difficult-to-treat cases of this condition.16789
Who Is on the Research Team?
Sebastian Unizony, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults with severe ANCA-associated vasculitis that's come back or hasn't responded to treatment can join. They need good heart, liver, kidney function, and a certain blood cell count. Must agree to birth control use and have no recent serious heart issues, high bleeding risk, active infections, drug-induced vasculitis or history of certain diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Participants undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine administered intravenously
Treatment
Participants receive CC-97540 CAR T cells infusion on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CC-97540
- Lymphodepletion Chemotherapy
Trial Overview
The trial is testing the safety of CC-97540 for patients whose vasculitis has relapsed or isn't responding to other treatments. It includes lymphodepletion chemotherapy before administering CC-97540 to prepare the body for the new therapy.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Prior to receiving CC-97540, participants will undergo lymphodepleting chemotherapy. Lymphodepleting chemotherapy is the combination of cyclophosphamide and fludarabine and will be administered intravenously. CC-97540 will be infused intravenously on day 0 only.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Marcela V. Maus, M.D.,Ph.D.
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
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
Citations
CC-97540 in Patients With Antineutrophil Cytoplasmic ...
The purpose of this study is to evaluate the safety of CC-97540 in relapsed or refractory severe antineutrophil cytoplasmic antibody (ANCA)- ...
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 ...
Outcomes with chimeric antigen receptor T-cell therapy in ...
In this systematic review, we aim to present the available data on the implications of CAR-T therapy in autoimmune diseases, summarizing responses as documented ...
4.
medcommsvdp.web.bms.com
medcommsvdp.web.bms.com/f5f8ca35-de1c-4635-8ba4-c127a1709f00/6d003fa0-b4c0-416f-bb55-ddf4c86940bd/6d003fa0-b4c0-416f-bb55-ddf4c86940bd_source__v.pdfTolerability and efficacy of BMS-986353 (CC-97540), a ...
term outcomes in SSc-associated ILD. Preliminary data following CD19-directed. CAR T cell therapy have demonstrated an unprecedented increase in FVC from ...
CAR-T-Cell Therapy for Systemic Lupus Erythematosus - PMC
Preliminary efficacy data for the first 3 patients showed: Clinical and Serological Responses: -Significant reductions in SLE Disease Activity Index (SLEDAI) ...
A Phase 1, Multicenter, Open-Label Study to Establish the ...
Conclusion: Results from first pts indicate promising preliminary safety and efficacy of CC-97540 at low doses. The data also show robust CAR T cell expansion ...
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 ...
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 ...
CARing about autoimmune disorders. Use of chimeric ...
Long-term safety data remain limited, and ongoing investigations ... Drug: CC-97540 (CD19-Targeted NEX-T CAR T Cells) Drug: Fludarabine
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