Safety and Efficacy Study of CC312 for Moderate to Severe SLE
ConditionSLE - Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCytoCares Inc
About this trial
This study is a randomized, double-blind, placebo-controlled Phase I clinical trial featuring single and multiple ascending doses. It is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of CC312 in adult patients with moderate to severe systemic lupus erythematosus (SLE).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.
Aged 18 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR/ACR classification criteria.
SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.
Disqualifiers
Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein >6 g/24 h, or serum creatinine >2.5 mg/dL or 221 μmol/L, or requiring prohibited medications for active nephritis per protocol, or needing hemodialysis, or receiving prednisone ≥100 mg/d or equivalent glucocorticoids for ≥14 days).
Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, CNS vasculitis) within 8 weeks prior to screening, whether SLE-related or not.
History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
Other concurrent autoimmune diseases requiring systemic therapy, except for Sjögren's syndrome.
Trial design
Design model
Parallel
Treatments tested in this trial
CC312
DrugSubjects will initially receive a single intravenous dose of CC312. After a 21-day period following the first dose, the patient may proceed to the multiple intravenous dosing phase only after investigators and the sponsor have confirmed acceptable safety and tolerability.
Placebo
DrugSubjects will initially receive a single intravenous dose of Placebo. After a 21-day period following the first dose, the patient may proceed to the multiple intravenous dosing phase only after investigators and the sponsor have confirmed acceptable safety and tolerability.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: CC312Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events (AE)/serious adverse events (SAE)
All adverse events will be evaluated and graded according to the severity criteria of CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, with the exception of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which will be assessed using the ASTCT (American Society for Transplantation and Cellular Therapy) standard.
Time frame
2 yearsSecondary outcomes
1
Maximum Serum Concentration (Cmax) of CC312
Blood samples will be collected for serum concentration analysis at specific time points
Time frame
2 years2
Area Under the Concentration-time Curve (AUC) of CC312
The area under the concentration-time curve (AUC) was calculated using the linear trapezoidal rule.
Time frame
2 years3
Counts of peripheral B cells
Blood samples will be collected for CD19+ and CD20+ B cell subsets analysis at specific time points
Time frame
2 years4
Anti-double-stranded DNA antibody （anti-dsDNA antibody）
Blood samples will be collected at specific timepoints for anti-double-stranded DNA antibodies (anti-dsDNA) analysis.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov