Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
Purpose
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).
Condition
- Lupus Nephritis
Eligibility
- Eligible Ages
- Between 12 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single-arm, single group assignment, open-label
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Obe-cel |
|
Recruiting Locations
Syracuse, New York 13210
San Antonio, Texas 78229
More Details
- Status
- Recruiting
- Sponsor
- Autolus Limited
Detailed Description
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 (+7) to Day of Enrollment 2. Treatment Period: From Day -8 to Day 1 - Participants will be evaluated to confirm eligibility for lymphodepletion, and thereafter receive lymphodepletion. 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.