Obe-cel for Severe Systemic Lupus Erythematosus

Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)

Recruiting Phase 2 Interventional Study
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?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
12 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
35 (estimated)
Sponsor
Autolus Limited · Industry
Who this trial is looking for

This trial is looking for people aged 12 to 65 with severe lupus that is hard to treat and causing kidney problems. Participation involves receiving a single treatment of a drug called obe-cel after a procedure to prepare the body.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 12 and 65 years old.
  • I have been diagnosed with systemic lupus erythematosus (SLE).
  • I have active lupus nephritis.
  • I have high levels of specific autoantibodies in my blood.
  • I am willing to follow the study protocol.
  • I can give my written consent to participate or have a guardian do it.
  • I have severe, active SLE as defined by specific scoring.

You may not be able to join if

  • I have received anti-CD19 therapy before.
  • I have had more than one severe lupus flare during screening.
  • I have significant organ damage from SLE that won't improve.
  • I have a history of antiphospholipid antibody syndrome.
  • I have an active infection that is not under control.
  • I have had cancer in the last 2 years.
  • I have had a transplant of any organ or stem cells.

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 trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative * Ability and willingness to adhere to protocol's Schedule of Activities and other requirements * Participants must be 12 t…
Contacts

Autolus Ltd

+44 (0)203 911 4385

clinicaltrials@autolus.com

CONTACT