Rapcabtagene Autoleucel for Vasculitis

Recruiting at 9 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Disqualifiers: Other autoimmune diseases, inadequate organ function, 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: Up to 39 weeks

126 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial mentions a 'washout period' (time without taking certain medications), so you may need to stop some of your current medications before participating. However, the specific medications you need to stop are not detailed in the information provided.

How is the drug Rapcabtagene autoleucel different from other treatments for vasculitis?

Rapcabtagene autoleucel is a novel treatment for vasculitis that likely involves a unique mechanism of action compared to traditional therapies like glucocorticoids and immunosuppressive drugs, which are commonly used for this condition. While standard treatments focus on suppressing the immune system, Rapcabtagene autoleucel may offer a different approach, potentially involving targeted therapy, although specific details about its mechanism in vasculitis are not provided in the available research. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults aged 18-75 with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA), diagnosed per ACR/EULAR 2022 criteria and positive for ANCA-autoantibodies. Specific details on who cannot participate are not provided.

Inclusion Criteria

I tested positive for ANCA-autoantibodies.

I have severe active GPA or MPA.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of rapcabtagene autoleucel or comparator with concomitant glucocorticoids

Up to 39 weeks

Multiple visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Long-term follow-up

Participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up period

Up to 15 years

Treatment Details

Interventions

• Rapcabtagene autoleucel

Trial Overview The trial is testing the effectiveness and safety of a therapy called Rapcabtagene autoleucel compared to an active comparator in treating severe GPA or MPA, both forms of vasculitis.

Participant Groups

Group I: Rapcabtagene autoleucel Experimental Treatment 2 Interventions

Single infusion of rapcabtagene autoleucel (YTB323) and concomitant glucocorticoids as per protocol

Group II: Active comparator Active Control 2 Interventions

Comparator and concomitant glucocorticoids as per protocol

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

References

1. England pubmed.ncbi.nlm.nih.gov

Etoposide: more effective and less bone-marrow toxic than standard immunosuppressive therapy in systemic vasculitis? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study. [2020]

3. Spain pubmed.ncbi.nlm.nih.gov

[Maintainance treatment of anti-neutrophil cytoplasm associated antibodies (ANCA)]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Update on the use of biologics in vasculitides. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Prednisone plus azathioprine treatment in patients with rheumatoid arthritis complicated by vasculitis. [2013]