BridgeMD
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
EU CTIS ID: 2024-519941-32-00
What this study is testing
To evaluate the efficacy of obe-cel as measured by the 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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus.
- Positive for at least 1 of the following autoantibodies: ANA at a titer of ≥ 1:80, or anti-dsDNA or anti-Sm.
- Severe, Active SLE
- Severe active LN
- Refractory SLE
You likely can't join if
- Within 1 month prior to leukapheresis to 7 days before leukapheresis: - Use of anti-CD20 therapy. - Immunization with a live or attenuated vaccine. - New therapy classes or drugs not previously used for the individual participant’s treatment.
- Active or uncontrolled fungal, bacterial, viral (e.g., pneumocystis or tuberculosis, or atypical mycobacteria, cytomegalovirus, herpes simplex or zoster infections, or coronavirus disease 2019), or other infection requiring systemic antimicrobials for management from 30 days prior to screening through obe-cel treatment.
- Active or latent hepatitis B or active hepatitis C.
- History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant.
- Human immunodeficiency virus, human T-lymphotropic virus 1 or 2, or syphilis-positive test at screening.
- History of or current malignant neoplasms unless disease-free for at least 5 years (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed).
See the full eligibility criteria
Who can join
- Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus.
- Positive for at least 1 of the following autoantibodies: ANA at a titer of ≥ 1:80, or anti-dsDNA or anti-Sm.
- Severe, Active SLE
- Severe active LN
- Refractory SLE
What rules you out
- Within 1 month prior to leukapheresis to 7 days before leukapheresis: - Use of anti-CD20 therapy. - Immunization with a live or attenuated vaccine. - New therapy classes or drugs not previously used for the individual participant’s treatment.
- Active or uncontrolled fungal, bacterial, viral (e.g., pneumocystis or tuberculosis, or atypical mycobacteria, cytomegalovirus, herpes simplex or zoster infections, or coronavirus disease 2019), or other infection requiring systemic antimicrobials for management from 30 days prior to screening through obe-cel treatment.
- Active or latent hepatitis B or active hepatitis C.
- History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant.
- Human immunodeficiency virus, human T-lymphotropic virus 1 or 2, or syphilis-positive test at screening.
- History of or current malignant neoplasms unless disease-free for at least 5 years (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed).
- Planning pregnancy, pregnant, or lactating.
- Participants are not eligible if the below laboratory criteria are met during screening. NOTE: If 1 or more laboratory parameters do not satisfy eligibility, it may be repeated 1 time within the 30-day screening period after discussion with the Medical Monitor. a. Neutrophil count < 1,000/μL b. Platelet count < 50,000/μL c. Hemoglobin < 7 g/dL for SLE-related hemolytic anemia or < 8 g/dL for all other participants d. Evidence of B cell aplasia e. Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) > 2.5 × ULN f. Total bilirubin > 1.5 × ULN for participants without Gilbert’s syndrome or direct bilirubin > 1 × ULN in participants with Gilbert’s syndrome g. International normalized ratio (INR) and activated partial thromboplastin clotting time (aPTT) > 1.5 ULN
- Left ventricular ejection fraction < 45% (or < institute’s lower limit of normal) confirmed by echocardiogram (ECHO).
- Oxygen saturation (SpO2)< 90% in the absence of oxygen support.
- Prior treatment at any time with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy).
- Recurrent neuropsychiatric lupus at any point prior to screening, or active, severe, or unstable neuropsychiatric lupus within 1 year from screening.
- History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites.
- Any other investigational treatments must have had a wash out of at least 5 half-lives.
- More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible; thus, making the participant ineligible for CD19 CAR T therapy (1 treatment of flare is allowed and participant must be fully rescreened; such cases should be discussed with the Medical Monitor).
- History or presence of: Within 3 months before screening visit: - Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, or stroke. - Evidence of deep venous thrombosis or pulmonary embolism.
- Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease [ESRD]) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant. Potential participants requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require these during the duration of the study are excluded from study participation.
- Diagnosis of clinically significant uveitis.
- History or presence of severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.
- History or presence of antiphospholipid antibody syndrome.
- Clinically significant, uncontrolled heart disease not due to SLE (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmia, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless the participant has a pacemaker) or a recent (within 12 months of screening) cardiac event.
The study team makes the final eligibility decision.
Where it's taking place
- Brazil
- United Kingdom
- Vietnam
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brazil; United Kingdom; Vietnam; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.