Equecabtagene Autoleucel Injection (Eque-cel) for Relapsed/Refractory Systemic Lupus Erythematosus (SLE)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital
About this trial
This is a single-center, open-label, exploratory clinical study to evaluate the efficacy and safety of Equecabtagene Autoleucel Injection (Eque-cel) in patients with Relapsed /refractory systemic lupus erythematosus (SLE).
Eligibility criteria
Qualifiers
Age≥18 years old, male or female;
Subjects must be diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria, or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria; the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥8, with a British Isles Lupus Assessment Group 2004 (BILAG-2004) activity score of A in ≥1 organ at screening, or a BILAG-2004 activity score of B in ≥2 organs.
Subjects with lupus nephritis (LN) must be diagnosed with active, biopsy-confirmed lupus nephritis of type III, IV, or V, or type III/IV combined with type V according to the 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria; the SLEDAI-2000(SLEDAI-2K) score ≥8;
Regular treatment with glucocorticoids and at least two immunosuppressants，immunomodulators, antimalarials, or biologics for at least 3 months, but withpoorly-controlled symptoms or intolerance to treatment.
Disqualifiers
Disease involved the nervous system with a BILAG-2004 activity score of Class A.
History of solid organ transplantation.
History of autologous or allogeneic stem cell transplantation.
History of prior cell therapy or treatment of BCMA-targeted drug.
Trial design
Treatments tested in this trial
- Equecabtagene Autoleucel Injection
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Tongji Hospital
Lead sponsor
Nanjing IASO Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov