BCMA-CD19 cCAR T for the Treatment of Refractory Lupus
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16-70
SponsoriCell Gene Therapeutics
About this trial
This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15/IL15sushi cCAR T cells in patients with relapsed and/or refractory SLE, with or without Lupus Nephritis.
Eligibility criteria
Qualifiers
Age 16-70 years at the time of signing the informed consent
Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months.
Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody
Inadequate response to 2 prior standard of care therapies, used for at least three months
Disqualifiers
Any acute, severe lupus related flare that needs immediate treatment
History of antiphospholipid syndrome with thromboembolic event within 12 months
History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.
Has drug-induced SLE.
Trial design
Treatments tested in this trial
- ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following cyclophosphamide-only lymphodepletion
Treatment groups
20 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov