Safety and Efficacy Study of CC312 for Moderate to Severe SLE

NCT07177911 | Recruiting Phase 1 DMC

• 1 other identifier: CC312-S-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

SLE - Systemic Lupus Erythematosus

Outcome Measures

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.

  2 years

Secondary Outcomes (6)

• Maximum Serum Concentration (Cmax) of CC312

  2 years

• Area Under the Concentration-time Curve (AUC) of CC312

  2 years

• Counts of peripheral B cells

  2 years

• Anti-double-stranded DNA antibody （anti-dsDNA antibody）

  2 years

• Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score

  2 years

Study Arms (2)

CC312

EXPERIMENTAL

Drug: CC312

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CC312 DRUG

Subjects 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.

CC312

Placebo DRUG

Subjects 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Received non-standard anti-SLE therapies (e.g., Saphnelo) within 3 months or 5 half-lives of the drug (whichever is longer) prior to screening.
• Received live/attenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.
• Active infection within 14 days prior to screening (bacterial, viral, fungal, parasitic, or other).
• History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (including recombinant proteins, polysorbate 80, etc.). Patients with transient (≤24 h) Grade ≤3 reactions may be included after discussion with the investigator.
• Evidence of drug abuse, substance abuse, or alcohol addiction.

Sponsors & Collaborators

• CytoCares Inc: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Related Publications (3)

• Murimi-Worstell IB, Lin DH, Kan H, Tierce J, Wang X, Nab H, Desta B, Alexander GC, Hammond ER. Healthcare Utilization and Costs of Systemic Lupus Erythematosus by Disease Severity in the United States. J Rheumatol. 2021 Mar;48(3):385-393. doi: 10.3899/jrheum.191187. Epub 2020 Jul 1.

  PMID: 32611669 BACKGROUND

• Gergianaki I, Bortoluzzi A, Bertsias G. Update on the epidemiology, risk factors, and disease outcomes of systemic lupus erythematosus. Best Pract Res Clin Rheumatol. 2018 Apr;32(2):188-205. doi: 10.1016/j.berh.2018.09.004. Epub 2018 Sep 27.

  PMID: 30527426 BACKGROUND

• Tsokos GC. Systemic lupus erythematosus. N Engl J Med. 2011 Dec 1;365(22):2110-21. doi: 10.1056/NEJMra1100359. No abstract available.

  PMID: 22129255 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

CEO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 10, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)