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New treatment option for Systemic Lupus Erythematosus
Official title Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06333483
What this study is testing
What is Obecabtagene autoleucel (obe-cel)?
Obecabtagene autoleucel (obe-cel) is an investigational medicine, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- -Key -
- Women or men ≥ 18 years at screening [Spain only] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent [UK only]
- Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for...
- Positive for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or...
- Severe, refractory SLE
You likely can't join if
- -Key Exclusion Criteria-
- Medications
- Within 2 months of leukapheresis: use of anti-CD20 therapy
- Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)
- Immunization with a live or attenuated vaccine within 2 months of leukapheresis
- SLE and Autoimmunity:
See the full eligibility criteria
- -Key -
- Women or men ≥ 18 years at screening [Spain only] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent [UK only]
- 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 one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or anti-Smith (\> upper limit of normal [ULN]), anti-histone or anti-chromatin (\>...
- Severe, refractory SLE
- -Key Exclusion Criteria-
- Medications
- Within 2 months of leukapheresis: use of anti-CD20 therapy
- Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)
- Immunization with a live or attenuated vaccine within 2 months of leukapheresis
- SLE and Autoimmunity:
- Recurrent neuropsychiatric lupus or active, severe or unstable neuropsychiatric lupus within 2 years from screening
- Diagnosis of drug-induced SLE rather than idiopathic SLE
- Any acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible; thus, making the patient ineligible for CD19 CAR T therapy as judged by the...
- 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 patient
- Diagnosis of another non-SLE autoimmune disease (e.g., dermatomyositis, polymyositis, scleroderma, rheumatoid arthritis) or overlap syndrome
- Medical History:
- 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
- History or presence of severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis
- 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...
- Active or uncontrolled fungal, bacterial, viral (including COVID-19), or other infection requiring systemic antimicrobials for management
- Active or latent hepatitis B or active hepatitis C
- Human immunodeficiency virus, human T-cell leukemia virus (HTLV)-1, HTLV-2 or syphilis positive test at screening
- History of malignant neoplasms unless disease free for at least 24 months (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed)
- History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant
- Pregnancy or lactating
- Laboratory and Organ Function:
- Left ventricular ejection fraction \< 45% (or \< institute's lower limit of normal) confirmed by echocardiogram
- Oxygen saturation (SpO2) \< 90% in the absence of oxygen support
- B cell aplasia
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Valencia, Spain
- Cambridge, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
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, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Valencia, Spain; Cambridge, United Kingdom; London, United Kingdom; Manchester, United Kingdom. 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 ClinicalTrials.gov; the study team decides eligibility.