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SLE - Systemic Lupus ErythematosusEarly Phase 1NCT07193810

A Study of CC312 for Relapsed/Refractory Autoimmune Diseases

A Early Phase 1 study testing CC312 in people with SLE - Systemic Lupus Erythematosus and IIM- Idiopathic Inflammatory Myopathies, run by CytoCares Inc at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
CC312
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
23 Sep 2025to 29 Sep 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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；
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  • 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；
  • Prior to the first dose, subjects must have received glucocorticoids and/or immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. Glucocorticoid dose must be ≤60 mg/day prednisone during screening；
  • If a subject is receiving oral glucocorticoids alone, the dose should be at least 7.5 mg/day of prednisone (or an equivalent dose of other glucocorticoids).
  • For Systemic Sclerosis (SSc):
  • Diagnosed with diffuse cutaneous SSc per the 2013 EULAR/ACR criteria ；
  • Have positive ANA and/or SSc-related antibodies；
  • Disease duration ≤5 years (from initial diagnosis)；
  • Had an inadequate response or relapse after conventional therapy. Conventional therapy is defined as treatment with glucocorticoids plus any of the following immunomodulatory agents: cyclophosphamide, mycophenolate mofetil, methotrexate, leflunomide, azathioprine, tacrolimus, cyclosporine, and/or biologics (such as rituximab and belimumab), with a cumulative treatment duration of >6 months；
  • Modified Rodnan Skin Score (mRSS) ≥15 and ≤30 at screening with progression within 6 months；
  • Prior to the first dose, subjects must have received glucocorticoids and/or immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. The glucocorticoid dose during the screening period should not exceed 10 mg/day of prednisone (or an equivalent dose of other glucocorticoids).
  • Females of childbearing potential must use highly effective contraception from screening until 6 months after the last dose, refrain from oocyte donation, and ensure male partners use effective contraception.
  • Males of childbearing potential must use effective contraception from screening until 6 months after the last dose, with no plans for fertility or sperm donation, and ensure female partners use effective contraception.

Who cannot join

  • 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.
  • Other types of idiopathic inflammatory myopathies: inclusion body myositis, amyotrophic diabetes, or juvenile myositis; patients with severe muscle damage or permanent weakness/cardiac involvement due to non-IIM causes (e.g., stroke).
  • 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.
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  • 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.
  • Major surgery within 4 weeks or minor surgery within 2 weeks prior to screening; wounds must be fully healed (procedures like catheter placement are excluded).
  • History of cardiovascular events within 6 months prior to screening: New York Heart Association (NYHA) Class III/IV heart failure, myocardial infarction, unstable angina, uncontrolled/symptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac conditions.
  • Any other severe underlying disease (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, GI bleeding, severe coagulation disorders), psychiatric disorder, or social circumstances that may interfere with trial conduct, compliance, or pose high risk per investigator's judgment.
  • Concurrent malignancy diagnosed within <5 years prior to screening.
  • Pregnant or lactating women.
  • Positive serology for Human Immunodeficiency Virus (HIV) antibody, Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) antibody, or Treponema pallidum (TP) antibody at screening.
  • Active or latent tuberculosis at screening (positive TB-IGRA test).
  • Any other condition deemed ineligible by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

CEO contact

+86-021-50582090

yingfeng.huang@cytocares.com

China1 site, 1 recruiting

  • Deyang People's Hospital

    Deyang, Sichuan, 618000

    Lin Feng, +86-18090757371, 18090757371@163.com

    Recruiting

Other trials in China

About this study

Official title: Exploratory Clinical Study on the Safety and Preliminary Efficacy of CC312 in the Treatment of Relapsed/Refractory Autoimmune Diseases

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.

Being tested
CC312
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CC312Biological

    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.

Study groups in NCT07193810
Study groupRoleWhat they receive
CC312ExperimentalNot described
Receives: Biological: CC312

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

Secondary outcomes (14)

  1. Serum Concentration of CC312

    All subjects are required to undergo blood sampling for serum concentration analysis at the following time points: within 1 hour before the guide dose (0 h) and 1 hour after infusion; for the treatment dose, within 1 hour before administration (0 h) and 1 hour after infusion on the first and second dosing occasions of the first and third treatment weeks, within 1 hour before administration (0 h) and 1 hour after infusion on the first dosing occasion of the second and fourth treatment weeks; and at early withdrawal/end of study (EOS).

    Measured: 2 years

  2. Counts of peripheral B cells

    All subjects are required to undergo blood sampling for peripheral B cells analysis at the following time points:within 1 hour before the priming dose (0 h), and 1 hour and 24 hours after infusion; for the treatment dose, within 1 hour before administration (0 h) and 1 hour and 24 hours after infusion on the first and second dosing occasions of Weeks 1 and 3, within 1 hour before administration (0 h) on the first dosing occasions of Week 2 and Week 4; if dosing is extended beyond Day 28, within 1 hour before the second weekly dose until the end of the extended dosing period; after the last dose, once monthly for 4 consecutive months; during the long-term follow-up period, once every 3 months; and at early withdrawal/end of study (EOS).

    Measured: 2 years

  3. Cytokines

    All subjects are required to undergo blood sampling for cytokine analysis (IFN-γ、IFN-α、IL-2、IL-6、IL-10、TNF-α) at the following time points: within 1 hour before the priming dose (0 h), and 1 hour and 24 hours after infusion; for the treatment dose, within 1 hour before administration (0 h) and 1 hour and 24 hours after infusion on the first and second dosing occasions of Weeks 1 and 3; within 1 hour before administration (0 h) and 1 hour and 24 hours after infusion on the first dosing occasion of Weeks 2 and 4; and at early withdrawal/EOS.

    Measured: 2 years

  4. Complement

    Blood samples for complement analysis will be collected from all subjects at the following time points: Screening/Baseline, within 1 hour before the priming dose (0 h); for the treatment dose, within 1 hour before the first weekly administration at Weeks 1, 2, 3, and 4, and at Weeks 8, 12, 24, and 48, as well as at early withdrawal.

    Measured: 2 years

  5. Autoantibody

    For patients with systemic lupus erythematosus, anti-double-stranded DNA antibody (anti-dsDNA) shall be tested at the following time points: within 1 hour before the priming dose (0 h), within 1 hour before the first treatment dose at Week 3, and on Day 28. Other autoantibodies shall be tested at the following time points: within 1 hour before the priming dose (0 h), on Day 28, and at Weeks 8, 12, 24, 48, as well as at early withdrawal.

    Measured: 2 years

  6. Immunogenicity

    Blood samples for immunogenicity analysis will be collected from all subjects at the following time points: within 1 hour before the priming dose (0 h), and within 1 hour before the first weekly treatment dose at Weeks 1, 2, 3, and 4; as well as at Weeks 8, 12, 16, and 24, and at early withdrawal or end of study (EOS).

    Measured: 2 years

  7. SLE Responder Index-4 (SRI-4) response rate

    SLE Responder Index-4 (SRI-4) response rate will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  8. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score

    SLEDAI-2K score will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  9. British Isles Lupus Assessment Group Index 2004 (BILAG-2004)

    BILAG-2004 (for SLE patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  10. 24-hour urinary protein quantification

    24-hour urinary protein quantification (for SLE patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  11. Physician's and Patient's Global Assessment of disease activity (PGA and PtGA)

    PGA and PtGA (for SLE patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  12. Total Improvement Score (TIS)

    TIS (for IIM patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  13. EUSTAR Activity Index (EUSTAR-AI)

    EUSTAR-AI (for SSc patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

  14. modified Rodnan Skin Score (mRSS)

    mRSS (for SSc patients) will be assessed at the following time points: during the screening period, at baseline (prior to the first dose), at the end of Week 2 and Week 4, at safety follow-up visits, and at the end of study (EOS). Additionally, during the post-treatment follow-up period, assessments will be conducted every 12 weeks (i.e., at Weeks 12, 24, 36, and 48, respectively).

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start23 Sep 2025
  3. Primary completion29 Sep 2027 (estimated)
  4. Study completion29 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07193810
Sponsor's protocol ID
CC312-I-003
Status last verified
Apr 2026
First submitted
15 Sep 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 23264339

  • 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.

    PubMed 37156255

  • 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.

    PubMed 31421964

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CC312 in people with SLE - Systemic Lupus Erythematosus and IIM- Idiopathic Inflammatory Myopathies, run by CytoCares Inc at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact CEO (+86-021-50582090, yingfeng.huang@cytocares.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07193810, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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