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New treatment option for Lupus Nephritis
Official title Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
ClinicalTrials.gov ID: NCT07053800
What this study is testing
What is Obecabtagene autoleucel?
Obecabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Also referred to as Obe-cel.
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
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65
You may be able to join if
- Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or...
- 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...
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Syracuse, New York, United States
- San Antonio, Texas, United States
- Athens, Greece
- Pátrai, Greece
- Birmingham, United Kingdom
- Bristol, United Kingdom
- Cambridge, United Kingdom
- Edinburgh, United Kingdom
- Glasgow, 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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Syracuse, New York, United States; San Antonio, Texas, United States; Athens, Greece; Pátrai, Greece; Birmingham, United Kingdom; Bristol, United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.