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Safety and Efficacy Study of CC312 for Moderate to Severe SLE | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Safety and Efficacy Study of CC312 for Moderate to Severe SLE

A Phase I Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of CC312 in Patients With Moderate-to-Severe Systemic Lupus Erythematosus

NCT07177911•CytoCares Inc

View on ClinicalTrials.gov

Summary

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

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Meet at least one of the following criteria: positive antinuclear antibody (ANA) ≥1:80 at screening, positive anti-dsDNA antibody at screening, or positive anti-Sm antibody at screening.
•Have had an inadequate response to at least two standard therapies (e.g., corticosteroids, antimalarials, immunosuppressants, biologics) prior to screening, including at least one immunosuppressant and/or biologic. Prior to the first dose, subjects must have been on a stable dose of corticosteroids (e.g., ≤40 mg/day prednisone or equivalent at screening and during the screening period; if used alone, ≥7.5 mg/day prednisone or equivalent) and/or antimalarials and/or immunosuppressants for at least 12 weeks, with doses stable for ≥30 days.
•Females of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose and refrain from oocyte collection or donation during this period. Their male partners of childbearing potential must also use effective contraception.
•Males of childbearing potential must agree to use highly effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation. Their female partners of childbearing potential must also use effective contraception during this period.

Exclusion Criteria

•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.
•IgA deficiency (serum IgA level \<10 mg/dL).
•Abnormal laboratory findings at screening:
•Liver function: AST/ALT or total bilirubin \>2× upper limit of normal (ULN); Hematology: hemoglobin \<85 g/L, WBC \<2.5×10⁹/L, neutrophil count \<1.0×10⁹/L, platelet count \<50×10⁹/L; Renal function: eGFR \<30 mL/min/1.73 m²;
•Participation in any other clinical trial (including cell or gene therapy) within 4 weeks prior to screening or within 5 half-lives of the investigational product (whichever is longer).
•Received CAR-T therapy within 6 months prior to screening.
•Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19/CD20/BAFF) within 6 months prior to screening, unless B-cell levels have returned to pre-treatment or normal ranges.
+13 more criteria

Locations (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

September 11, 2025

Primary Completion Date

September 10, 2027

Completion Date

September 10, 2027

Last Updated

September 17, 2025

Enrollment

ESTIMATED participants

Conditions

SLE - Systemic Lupus Erythematosus

Interventions

CC312

DRUG

Placebo

DRUG

Contacts

CEO

CONTACT

+86-021-50582090 yingfeng.huang@cytocares.com