NCT07053800 · Autolus Limited
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
(LUMINA)
What this study is about
The purpose of this trial is to evaluate the effectiveness 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).
View original scientific description
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).
Interventions
BIOLOGICAL
Obecabtagene autoleucel
Obecabtagene autoleucel (obe-cel) given as a single infusion
Primary outcome measures
Proportion of participants who achieve complete renal response (CRR)
Time frame: Month 6
CRR is a composite endpoint
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 to 65 years of age inclusive at the time of signing the informed consent.
- Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding
- Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.
- Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.
- Severe, Active SLE defined as:
- SLEDAI-2K score of ≥ 8 points AND
- Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)
- Refractory SLE defined as failure to previous lines of therapy
Exclusion criteria
- Prior treatment at any time with anti-CD19 therapy
- More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible
- Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant
- History of primary antiphospholipid antibody syndrome
- Active or uncontrolled fungal, bacterial, or viral infection
- History of malignant neoplasms unless disease free for at least 24 months
- History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant
Where
- Syracuse, New York
- San Antonio, Texas
Collaborators
PPD Development, LP
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations