Obecabtagene autoleucel: Obecabtagene autoleucel (obe-cel) given as a single infusion
Study 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).
Eligibility
Sex
ALL
Min age
12 Years
Max age
65 Years
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
Primary outcome measure(s)
Proportion of participants who achieve complete renal response (CRR) — Month 6 CRR is a composite endpoint
Trial sites (15)
Facility
City
Region
Status
Icahn School of Medicine at Mount Sinai
New York
New York
Recruiting
State University of New York Upstate Medical Center (SUNY)
Syracuse
New York
Recruiting
Texas Transplant Institute
San Antonio
Texas
Recruiting
Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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