35 Participants NeededMy employer runs this trial

Obe-cel for Lupus Nephritis

(LUMINA Trial)

Recruiting at 24 trial locations
AL
Overseen ByAutolus Ltd
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Autolus Limited
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find out if obe-cel gets rid of harmful B cells that contribute to systemic lupus erythematosus (SLE)/lupus nephritis (LN) when available treatments have not worked (refractory). The trial includes only 1 group of patients (single arm), including adolescent and adult patients aged 12 to 65 years. The objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after obe-cel treatment in patients with severe, active LN. The trial will also look for other benefits of obe-cel for up to 24 months after treatment, including the percentage of patients who respond to obe-cel treatment, SLE/LN activity, time to and length of remission, and quality of life. The trial will also assess how long obe-cel stays in the body and the safety of obe-cel.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am not pregnant or breastfeeding.
I have been diagnosed with systemic lupus erythematosus (SLE).
My lupus has not improved with standard treatments, calcineurin inhibitors, or B cell drugs.
See 5 more

Exclusion Criteria

Any medications prohibited by the protocol
I have been treated with anti-CD19 therapy before.
History of primary antiphospholipid antibody syndrome
See 5 more

What Are the Treatments Tested in This Trial?

Interventions

  • Obecabtagene Autoleucel

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Obe-celExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Autolus Limited

Lead Sponsor

Trials
9
Recruited
1,000+

PPD Development, LP

Industry Sponsor