Recruiting
Phase 2

Obecabtagene Autoleucel

Sponsor:

Autolus Limited

Code:

NCT07053800

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

Interventions

Obecabtagene autoleucel

Study Details

Brief summary:

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).

Conditions

Lupus Nephritis

Study ID

NCT07053800

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Obe-cel

Interventions

Obecabtagene autoleucel

Obecabtagene autoleucel (obe-cel) given as a single infusion

Primary outcome measure

  • Proportion of participants who achieve complete renal response (CRR) [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Autolus Ltd

+44 (0)203 911 4385clinicaltrials@autolus.com

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

State University of New York Upstate Medical Center (SUNY)

Recruiting

Syracuse, New York, United States, 13210

Texas Transplant Institute

Recruiting

San Antonio, Texas, United States, 78229

More Information

Sponsor

Autolus Limited

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Systemic lupus erythematosus
  • Refractory systemic lupus erythematosus
  • Lupus nephritis
  • Obecabtagene autoleucel
  • Obe-cel

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Autolus Limited on 2026-08-24.