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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Obecabtagene autoleucel (obe-cel) given as a single infusion
Icahn School of Medicine at Mount Sinai
New York, New York, United States
RECRUITINGState University of New York Upstate Medical Center (SUNY)
Syracuse, New York, United States
Proportion of participants who achieve complete renal response (CRR)
CRR is a composite endpoint
Time frame: Month 6
Proportion of participants achieving remission per Definition of Remission in SLE (DORIS) criteria
DORIS is a composite endpoint
Time frame: Month 6
Proportion of participants achieving CRR over time
CRR is a composite endpoint
Time frame: Up to Month 24
Time to CRR
CRR is a composite endpoint
Time frame: Up to Month 24
Proportion of participants with Partial Renal Response (PRR)
PRR is a composite endpoint
Time frame: Up to Month 24
Time to PRR
PRR is a composite endpoint
Time frame: Up to Month 24
Proportion of participants achieving remission per DORIS criteria over time
DORIS is a composite endpoint
Time frame: Up to Month 24
Time to achieving remission per DORIS criteria
DORIS is a composite endpoint
Time frame: Up to Month 24
Time to renal flare
Renal flare is a composite endpoint
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Texas Transplant Institute
San Antonio, Texas, United States
RECRUITINGInstituto D´Or de Pesquisa e Ensino - Hospital São Rafael
Salvador, Estado de Bahia, Brazil
RECRUITINGUniversity General Hospital ATTIKON
Athens, Greece
RECRUITINGUniversity General Hospital of Patras
Pátrai, Greece
RECRUITINGQueen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
RECRUITINGBristol Haematology and Oncology Centre
Bristol, United Kingdom
RECRUITINGAddenbrooke's Hospital
Cambridge, United Kingdom
RECRUITINGWestern General Hospital Edinburgh
Edinburgh, United Kingdom
RECRUITING...and 5 more locations
Time frame: Up to Month 24
Proportion of participants achieving Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 0 over time
SLEDAI-2K is a composite index of disease activity
Time frame: Up to Month 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS) over time
LLDAS is a composite endpoint
Time frame: Up to Month 24
Time to LLDAS
LLDAS is a composite endpoint
Time frame: Up to Month 24
Time to first disease flare according to Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI-2K Flare Index (SFI) post-obe-cel infusion
SFI is a composite index to identify disease flares
Time frame: Up to Month 24
To evaluate safety of obe-cel
Proportion of participants with adverse events (AEs)
Time frame: Up to Month 24