RecruitingRecruiting
Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
NCT07053800 · Autolus Limited
In plain English
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Official title
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
About this study
This is a Phase 2 study to determine the efficacy and safety of obe-cel in participants with severe, refractory SLE with active LN.
The study comprises 3 periods:
1. Screening Period: From Day -30 to Day of Enrolment
2. Treatment Period: From Day -8 to Day 1 - Patients will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion to enhance treatment efficacy and cluster of differentiation (CD)19 chimeric antigen receptor (CAR) T cell survival. Obe-cel Administration: If the participant's eligibility for receiving obe-cel infusion is confirmed, the participant is to receive a single obe-cel infusion on Day 1.
3. Post-treatment Period: From Day 1 to End of Study all participants will be followed up for efficacy and safety evaluation.
The primary objective is to look for benefits of obe-cel in making signs of LN completely disappear (remission) at 6 months after treatment.
Eligibility 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.
Study design
Enrollment target: 35 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2026-01-16
Estimated completion: 2029-10
Last updated: 2026-04-27
Interventions
Biological: Obecabtagene autoleucel
Primary outcomes
- • Proportion of participants who achieve complete renal response (CRR) at 6 months post-obe-cel infusion without rescue medications, among all participants who received obe-cel infusion (Month 6)
Sponsor
Autolus Limited · industry
With: PPD Development, LP
Contacts & investigators
ContactAutolus Ltd · contact · clinicaltrials@autolus.com · +44 (0)203 911 4385
All locations (26)
Banner MD Anderson Cancer Center at Canyon SpringsActive Not Recruiting
Gilbert, Arizona, United States
City of HopeActive Not Recruiting
Duarte, California, United States
Stanford UniversityActive Not Recruiting
Stanford, California, United States
Tampa General HospitalActive Not Recruiting
Tampa, Florida, United States
H Lee Moffitt Cancer Center and Research InstituteActive Not Recruiting
Tampa, Florida, United States
EmoryActive Not Recruiting
Atlanta, Georgia, United States
The Tisch Cancer Institute - 1470 Madison AvenueActive Not Recruiting
New York, New York, United States
State University of New York Upstate Medical Center (SUNY)Active Not Recruiting
Syracuse, New York, United States
Texas Childrens Hospital/BaylorActive Not Recruiting
Houston, Texas, United States
Accurate Clinical Research Inc - VictoriaActive Not Recruiting
Houston, Texas, United States
Texas Transplant InstituteActive Not Recruiting
San Antonio, Texas, United States
SER - Serviços Especializados em Reumatologia da Bahia S/S - MEActive Not Recruiting
Salvador, Estado de Bahia, Brazil
Hospital Sao RafaelActive Not Recruiting
Salvador, Estado de Bahia, Brazil
Centro de Estudos em Terapias InovadorasActive Not Recruiting
Curitiba, Paraná, Brazil
DASA - Hospital Nove de JulhoActive Not Recruiting
São Paulo, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)Active Not Recruiting
São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloActive Not Recruiting
São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloActive Not Recruiting
São Paulo, Brazil
Queen Elizabeth Hospital BirminghamActive Not Recruiting
Birmingham, United Kingdom
Bristol Haematology and Oncology CentreActive Not Recruiting
Bristol, United Kingdom
Addenbrooke's HospitalRecruiting
Cambridge, United Kingdom
Western General Hospital Edinburgh - PPDSActive Not Recruiting
Edinburgh, United Kingdom
Queen Elizabeth University Hospital - PPDSActive Not Recruiting
Glasgow, United Kingdom
University College Hospital - PPDSRecruiting
London, United Kingdom
Great Ormond Street Hospital - PPDSActive Not Recruiting
London, United Kingdom
Manchester Royal Infirmary - PPDSRecruiting
Manchester, United Kingdom