Obe-cel for severe, treatment-resistant lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, single-arm study gives one infusion of obe-cel after a short lymphodepletion regimen to adolescents and adults aged 12–65 with severe, refractory SLE and biopsy‑proven active lupus nephritis. Participants are screened, receive lymphodepletion around Day -8 to Day 1, then a single obe-cel infusion on Day 1, and are followed for up to 24 months for efficacy and safety. The primary endpoint is complete renal remission at 6 months, with additional outcomes including response rates, SLE/LN activity, time to and duration of remission, quality of life, pharmacokinetics/persistence, and adverse events. Study sites include Banner MD Anderson Cancer Center at Canyon Springs, City of Hope, and Stanford University.

Why it matters

Who can join: the full rules

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 it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• State University of New York Upstate Medical Center (SUNY)
  Syracuse, New York, United States Recruiting
• Texas Children's Hospital
  Houston, Texas, United States Recruiting
• Texas Transplant Institute
  San Antonio, Texas, United States Recruiting
• Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
  Salvador, Estado de Bahia, Brazil Recruiting
• University General Hospital ATTIKON
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Autolus Ltd
• Email: clinicaltrials@autolus.com
• Phone: +44 (0)203 911 4385

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

  This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.

  Recruiting Phase 1/2 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Badalona, Barcelona and 7 other locations · NCT07799116

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Biomarker tests in adults with lupus to see how kidney disease changes over time

  Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07666711

• LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis

  This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.

  Recruiting at 27 sites Phase 4 Aurinia Pharmaceuticals Inc. · La Mesa, California and 26 other locations · NCT07611214

• Mosunetuzumab for people with systemic lupus erythematosus

  This study tests mosunetuzumab in people with systemic lupus erythematosus, with or without active lupus nephritis.

  Recruiting at 24 sites Phase 2 Hoffmann-La Roche · CABA, Buenos Aires and 23 other locations · NCT07598396

• FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN

  This trial tests whether FT819, a donor-derived CAR T cell therapy, can help people with difficult-to-treat lupus nephritis who have not responded to other medicines.

  Recruiting at 12 sites Phase 2 Fate Therapeutics · Beverly Hills, California and 11 other locations · NCT07570862

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.