Rapcabtagene Autoleucel for Lupus Nephritis or SLE

A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)

Recruiting Phase 2 Interventional Study
Lupus Erythematosus, Systemic Lupus Nephritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
179 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adults with active systemic lupus erythematosus (SLE) or lupus nephritis that has not responded to previous treatments. Participants will receive a single treatment with rapcabtagene autoleucel after a prior lymphodepletion process.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I have been diagnosed with lupus erythematosus.
  • I have at least one specific autoantibody in my blood.
  • I have active lupus nephritis without chronic signs.
  • I have a SLEDAI-2K score of 6 or higher.
  • I have not responded well to at least two treatments.

You may not be able to join if

  • I have an acute lupus flare that needs immediate treatment.
  • I have poor organ function.
  • I have a history of serious heart issues.
  • I am HIV positive.
  • I have a current infection with hepatitis B or C.
  • I have had a serious blood clot in the last month.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel (administered once following lymphodepletion) in patients with active, refractory systemic lupus erythematosus (SLE) or active, refractory lupus nephritis (LN).

Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Men and women with SLE, aged \>= 18 years and =\< 75 years at screening, fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for SLE at screening. * Participant must be positive for at least one of t…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

+41613241111

novartis.email@novartis.com

CONTACT