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Obe-cel for severe, treatment-resistant lupus nephritis

A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis

Phase 2 Interventional Autolus Limited · NCT07053800

This study will test whether a single infusion of obe-cel, a CD19 CAR‑T cell therapy, can put adolescents and adults (ages 12–65) with severe, treatment‑resistant lupus nephritis into remission.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment35 (estimated)
Ages12 Years to 65 Years
SexAll
SponsorAutolus Limited Industry-sponsored
Drugs / interventionsCAR T, chimeric antigen receptor
Locations26 sites (Gilbert, Arizona and 25 other locations)
Trial IDNCT07053800 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients aged 12–65 with a diagnosis of SLE per 2019 EULAR/ACR criteria, a positive autoantibody, severe active lupus nephritis on a recent renal biopsy, a SLEDAI‑2K score ≥8, and disease refractory to available treatments.

Not a fit: Patients with mild or well‑controlled lupus nephritis, those who are pregnant or breastfeeding, those with contraindications to lymphodepletion or CAR‑T therapy, or those unable to travel to a study site are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, obe-cel could induce durable remission of lupus nephritis in patients who have not responded to standard therapies, potentially reducing long‑term kidney damage and the need for chronic immunosuppression.

How similar studies have performed: Early case reports and small cohorts of CD19 CAR‑T therapies in refractory SLE, including some patients with lupus nephritis, have reported promising remissions, but larger controlled data remain limited.

Eligibility criteria

Show full inclusion / exclusion 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 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:

  * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥ 8 points AND
  * Severe active LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V (V only in combination with class III or IV)
* Refractory SLE defined as failure to early lines of therapy and to Calcineurin inhibitors AND B cell-targeting agents

Exclusion Criteria:

* Any medications prohibited by the protocol.
* 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 this trial is running

Gilbert, Arizona and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Lupus NephritisSystemic lupus erythematosusRefractory systemic lupus erythematosusLupus nephritisObecabtagene autoleucelObe-cel
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.