A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

NCT07193810 | Recruiting Early Phase 1 DMC

• 1 other identifier: CC312-I-003
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an open-label, multiple ascending dose investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CC312 in adult patients with relapsed or refractory autoimmune diseases.

Conditions

SLE - Systemic Lupus Erythematosus; IIM- Idiopathic Inflammatory Myopathies; SSc-Systemic Sclerosis

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  A Dose-Limiting Toxicity (DLT) is defined as any adverse event occurring within the 29-day period following the initiation of CC312 intravenous infusion during the dose-escalation phase, assessed by the investigator as related to CC312 and meeting the following criteria: (1) Hematologic Toxicity: Grade 4 toxicity (excluding lymphopenia) persisting beyond 29 days and not attributable to underlying disease; (2) Non-Hematologic Toxicity: Any ≥Grade 4 toxicity potentially related to CC312 during the observation window, or any Grade 3 toxicity potentially related to CC312 that fails to resolve to ≤Grade 2 within 7 days.

  2 years

• Adverse events (AE)/serious adverse events (SAE)

  With the exception of CRS and ICANS, which will be graded according to the ASTCT criteria, the severity of all other adverse events (AEs) will be assessed and classified using the CTCAE (Common Terminology Criteria for Adverse Events) version 5.0.

  2 years

Secondary Outcomes (14)

• Serum Concentration of CC312

  2 years

• Counts of peripheral B cells

  2 years

• Cytokines

  2 years

• Complement

  2 years

• Autoantibody

  2 years

Study Arms (1)

CC312

EXPERIMENTAL

Biological: CC312

Interventions

CC312 BIOLOGICAL

The priming dose of CC312 will be administered intravenously on Day -3, followed by safety and tolerability evaluations on Day -1 (3 days post-first dose). The first therapeutic dose of CC312 will be administered on Day 1, with subsequent doses administered on Day 4, 8, and 11. Corresponding safety and tolerability assessments will be performed with each dose. Based on the evaluation of clinical efficacy, B-cell depletion, and safety/tolerability profile at the end of Day 14, the dose for the subsequent therapeutic dosing will be determined (maintained or escalated). Thereafter, therapeutic dosing will be administered on Days 15, 18, 22, and 25, accompanied by scheduled safety and tolerability assessments.

CC312

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 18-65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.
• For Systemic Lupus Erythematosus (SLE):
• Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria；
• Meet at least one of the following: positive antinuclear antibody (ANA) and/or anti-dsDNA antibody and/or anti-Sm antibody at screening；
• Had an inadequate response or relapse after standard therapy, defined as any of the following (alone or combined): glucocorticoids, antimalarials (hydroxychloroquine), immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, cyclosporine, azathioprine), or biologics (rituximab, belimumab, telitacicept). Each regimen must have been administered for ≥3 months, and the subject must have received ≥2 immunosuppressants and/or biologics；
• At screening, meet SLEDAI-2000 ≥7 and have at least one BILAG A or two BILAG B organ domain scores；
• Prior to the first dose, subjects must have received glucocorticoids and/or antimalarials and/or immunosuppressants for ≥12 weeks, with stable doses for ≥30 days；
• If receiving oral glucocorticoids (e.g., prednisone), the dose must be ≤40 mg/day at screening and during the screening period；
• If using glucocorticoids alone, the dose must be ≥7.5 mg/day prednisone (or equivalent).
• For Idiopathic Inflammatory Myopathy (IIM):
• Diagnosed with possible or definite IIM per the 2017 EULAR/ACR classification criteria (≥5.5 points without biopsy; ≥6.7 points with biopsy) ；
• Have at least one positive myositis-specific autoantibody (MSA) , myositis-associated autoantibody (MAA), or ANA at or prior to screening；
• Had an inadequate response or relapse after conventional therapy, defined as glucocorticoids (prednisone \>1 mg/kg/day or equivalent) and ≥1 immunomodulatory drug (immunosuppressants: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine; biologics: rituximab, belimumab; small molecules: tofacitinib), each for ≥3 months；
• Have active IIM at screening, defined as meeting ≥3 of MMT-8 total score ≤141/150 with ≥20% strength loss in affected muscles; Physician global activity ≥2; Patient global activity ≥2; myositis disease activity assessment tool (MDAAT) ≥2; ≥2 muscle enzymes elevated, with one ≥1.5× upper limit of normal (ULN); health assessment questionnaire (HAQ) ≥0.25；

You may not qualify if:

• Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \>6 g/24 h, serum creatinine \>2.5 mg/dL or 221 μmol/L), requirement of prohibited medications for active nephritis per protocol, need for hemodialysis, or receipt of prednisone ≥100 mg/day (or equivalent glucocorticoids) for ≥14 days.
• Central nervous system disorders (including but not limited to epilepsy, psychosis, interstitial encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis) within 8 weeks prior to screening.
• SSc-related pulmonary hypertension requiring treatment; rapidly progressive SSc-related lower gastrointestinal (small/large intestine) involvement requiring parenteral nutrition; active gastric antral vascular ectasia; history of SSc-related renal crisis.
• 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.
• IgA deficiency (serum IgA level \<10 mg/dL).
• Abnormal laboratory findings at screening: Liver function: AST/ALT \>2× upper limit of normal (ULN) (except for IIM patients with elevated muscle enzymes); Hematology: hemoglobin \<85 g/L, white blood cell count \<2.5×10⁹/L, platelet count \<50×10⁹/L.
• 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 1 month prior to screening, unless B-cell levels 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 severe infection requiring antibiotic treatment within 14 days prior to screening.
• History of Grade 3-4 allergic reaction (per CTCAE v5.0) to another monoclonal antibody, or known hypersensitivity to any component of CC312 (e.g., recombinant proteins, polysorbate 80). 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)

Deyang People's Hospital

Deyang, Sichuan, 618000, China

RECRUITING

Related Publications (3)

• Doria A, Amoura Z, Cervera R, Khamastha MA, Schneider M, Richter J, Guillemin F, Kobelt G, Maurel F, Garofano A, Perna A, Murray M, Schmitt C, Boucot I. Annual direct medical cost of active systemic lupus erythematosus in five European countries. Ann Rheum Dis. 2014 Jan;73(1):154-60. doi: 10.1136/annrheumdis-2012-202443. Epub 2012 Dec 21.

  PMID: 23264339 BACKGROUND

• Conrad N, Misra S, Verbakel JY, Verbeke G, Molenberghs G, Taylor PN, Mason J, Sattar N, McMurray JJV, McInnes IB, Khunti K, Cambridge G. Incidence, prevalence, and co-occurrence of autoimmune disorders over time and by age, sex, and socioeconomic status: a population-based cohort study of 22 million individuals in the UK. Lancet. 2023 Jun 3;401(10391):1878-1890. doi: 10.1016/S0140-6736(23)00457-9. Epub 2023 May 5.

  PMID: 37156255 BACKGROUND

• Karagianni P, Tzioufas AG. Epigenetic perspectives on systemic autoimmune disease. J Autoimmun. 2019 Nov;104:102315. doi: 10.1016/j.jaut.2019.102315. Epub 2019 Aug 15.

  PMID: 31421964 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: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 26, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): September 29, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)