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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Equecabtagene Autoleucel Injection
Drugdosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: 1.0 x 10^6 CAR+ T cellsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response rate of SRI-4 at 6 months after Eque-cel infusion
SLE Responder Index (SRI)-4 is defined as follows with all criteria compared to Baseline: * ≥ 4-point reduction in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. * No worsening of the overall condition (\< 0.3 point increase in Physician's Global Assessment \[PhGA\]) . * No new British Isles Lupus Assessment Group (BILAG) A or more than 1 new BILAG B disease activity scores.
Time frame
6 months post Eque-cel infusion.Secondary outcomes
1
lupus low disease activity state (LLDAS) rate through 2 years after Eque-cel infusion
Proportions of subjects achieving LLDAS by timepoint;
Time frame
up to 2 years from Eque-cel infusion2
Definitions of Remission in SLE (DORIS) rate through 2 years after Eque-cel infusion
Proportions of subjects achieving remission according to the DORIS as assessed by SLEDAI-2K Scale，PhGA Scale and concomitant medication usage.
Time frame
up to 2 years from Eque-cel infusion3
Complete and Partial Renal Response（Lupus Nephritis Patients）through 2 years after Eque-cel infusion
Proportion of Participants Who Achieve Overall Complete and Partial Renal Response (CRR+PRR).
Time frame
up to 2 years from Eque-cel infusion4
Safety Endpoint -Adverse Events（AEs）
Type and incidence of AEs as Assessed by CTCAE 5.0 (except CRS and ICANS assessed according to the criteria of NCI-CTCAE v5.0).
Time frame
up to 2 years from Eque-cel infusionOther outcomes
1
Immunogenicity
Presence of human anti-CAR antibodies, and titer of confirmed positive antibody in peripheral blood.
Time frame
up to 2 years from Eque-cel infusion2
C-reactive protein (CRP)
Changes in the levels of CRP.
Time frame
up to 2 years from Eque-cel infusion3
Ferritin
Changes in the levels of Ferritin.
Time frame
up to 2 years from Eque-cel infusion4
Interleukin-6 (IL-6)
Changes in the levels of IL-6.
Time frame
up to 2 years from Eque-cel infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tongji Hospital
Lead sponsor
Nanjing IASO Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov