Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)
ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorAutolus Limited
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Obecabtagene autoleucel
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Autolus Limited
Lead sponsor
PPD Development, LP
Collaborator
Source ClinicalTrials.gov