[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CytoCares Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100607842","early-phase-1-a-study-of-cc312-for-relapsedrefractory-autoimmune-diseases-100607842",false,"NCT07193810","A Study of CC312 for Relapsed\u002FRefractory Autoimmune Diseases","Exploratory Clinical Study on the Safety and Preliminary Efficacy of CC312 in the Treatment of Relapsed\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.\n* Aged 18-65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.\n* For Systemic Lupus Erythematosus (SLE):\n\n  1. Diagnosed with SLE according to the 2019 EULAR\u002FACR classification criteria；\n  2. Meet at least one of the following: positive antinuclear antibody (ANA) and\u002For anti-dsDNA antibody and\u002For anti-Sm antibody at screening；\n  3. 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\u002For biologics；\n  4. At screening, meet SLEDAI-2000 ≥7 and have at least one BILAG A or two BILAG B organ domain scores；\n  5. Prior to the first dose, subjects must have received glucocorticoids and\u002For antimalarials and\u002For immunosuppressants for ≥12 weeks, with stable doses for ≥30 days；\n  6. If receiving oral glucocorticoids (e.g., prednisone), the dose must be ≤40 mg\u002Fday at screening and during the screening period；\n  7. If using glucocorticoids alone, the dose must be ≥7.5 mg\u002Fday prednisone (or equivalent).\n* For Idiopathic Inflammatory Myopathy (IIM):\n\n  1. Diagnosed with possible or definite IIM per the 2017 EULAR\u002FACR classification criteria (≥5.5 points without biopsy; ≥6.7 points with biopsy) ；\n  2. Have at least one positive myositis-specific autoantibody (MSA) , myositis-associated autoantibody (MAA), or ANA at or prior to screening；\n  3. Had an inadequate response or relapse after conventional therapy, defined as glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fday 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；\n  4. Have active IIM at screening, defined as meeting ≥3 of MMT-8 total score ≤141\u002F150 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；\n  5. Prior to the first dose, subjects must have received glucocorticoids and\u002For immunosuppressants for ≥12 weeks, with stable glucocorticoid doses for ≥30 days and immunosuppressant doses for ≥60 days. Glucocorticoid dose must be ≤60 mg\u002Fday prednisone during screening；\n  6. If a subject is receiving oral glucocorticoids alone, the dose should be at least 7.5 mg\u002Fday of prednisone (or an equivalent dose of other glucocorticoids).\n* For Systemic Sclerosis (SSc):\n\n  1. Diagnosed with diffuse cutaneous SSc per the 2013 EULAR\u002FACR criteria ；\n  2. Have positive ANA and\u002For SSc-related antibodies；\n  3. Disease duration ≤5 years (from initial diagnosis)；\n  4. 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\u002For biologics (such as rituximab and belimumab), with a cumulative treatment duration of \\>6 months；\n  5. Modified Rodnan Skin Score (mRSS) ≥15 and ≤30 at screening with progression within 6 months；\n  6. Prior to the first dose, subjects must have received glucocorticoids and\u002For 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\u002Fday of prednisone (or an equivalent dose of other glucocorticoids).\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \\>6 g\u002F24 h, serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), requirement of prohibited medications for active nephritis per protocol, need for hemodialysis, or receipt of prednisone ≥100 mg\u002Fday (or equivalent glucocorticoids) for ≥14 days.\n* 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.\n* Other types of idiopathic inflammatory myopathies: inclusion body myositis, amyotrophic diabetes, or juvenile myositis; patients with severe muscle damage or permanent weakness\u002Fcardiac involvement due to non-IIM causes (e.g., stroke).\n* SSc-related pulmonary hypertension requiring treatment; rapidly progressive SSc-related lower gastrointestinal (small\u002Flarge intestine) involvement requiring parenteral nutrition; active gastric antral vascular ectasia; history of SSc-related renal crisis.\n* History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Other concurrent autoimmune diseases requiring systemic therapy.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Abnormal laboratory findings at screening: Liver function: AST\u002FALT \\>2× upper limit of normal (ULN) (except for IIM patients with elevated muscle enzymes); Hematology: hemoglobin \\\u003C85 g\u002FL, white blood cell count \\\u003C2.5×10⁹\u002FL, platelet count \\\u003C50×10⁹\u002FL.\n* 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).\n* Received CAR-T therapy within 6 months prior to screening.\n* Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19\u002FCD20\u002FBAFF) within 1 month prior to screening, unless B-cell levels returned to pre-treatment or normal ranges.\n* 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.\n* Received live\u002Fattenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.\n* Active severe infection requiring antibiotic treatment within 14 days prior to screening.\n* 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.\n* Evidence of drug abuse, substance abuse, or alcohol addiction.\n* 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).\n* History of cardiovascular events within 6 months prior to screening: New York Heart Association (NYHA) Class III\u002FIV heart failure, myocardial infarction, unstable angina, uncontrolled\u002Fsymptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac conditions.\n* 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.\n* Concurrent malignancy diagnosed within \\\u003C5 years prior to screening.\n* Pregnant or lactating women.\n* 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.\n* Active or latent tuberculosis at screening (positive TB-IGRA test).\n* Any other condition deemed ineligible by the investigator.","ALL","18 Years","65 Years",{"count":20,"type":21},6,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","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.",[27,28,29],"SLE - Systemic Lupus Erythematosus","IIM- Idiopathic Inflammatory Myopathies","SSc-Systemic Sclerosis","RECRUITING","2026-04-09",{"date":33,"type":34},"2026-04-14","ACTUAL",{"date":36,"type":34},"2025-09-23",{"date":38,"type":21},"2027-09-29",{"name":40,"class":41},"CytoCares Inc","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":42},"100518936","phase-1-safety-study-of-cc312-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-100518936","NCT06037018","Safety Study of CC312 in Adult Patients With Relapsed\u002FRefractory CD19 Positive B-cell Hematologic Malignancies","A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of CC312 in Adult Patients With Relapsed\u002FRefractory CD19 Positive B-cell Hematologic Malignancies","Inclusion Criteria:\n\n1. CD19 positive B-cell malignancies confirmed as one of the following: aggressive or indolent B-cell NHL, philadelphia chromosome-positive or -negative B-cell ALL, or B-cell CLL; patient must meet the definition of relapse\u002Frefractory before enrollment.\n2. ECOG (Eastern Cooperative Oncology Group) performance status 0-2, life expectancy \\>3 months；\n3. Clinical laboratory values as specified below during the Screening period.\n\n   * Total bilirubin \\\u003C1.5 ULN, may be elevated up to 3 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in the liver or in patients with documented Gilbert's Syndrome;\n   * ALT or AST \\\u003C3ULN, may be elevated up to 5 x ULN if the elevation can be reasonably ascribed to the presence of metastatic disease in liver;\n   * Calculated creatinine clearance \\> 50 mL\u002Fmin (The Cockcroft-Gault formula);\n   * Hemoglobin ≥ 7 g\u002FdL;\n   * Neutrophil count \\> 1,000\u002Fmm3 for B-cell NHL patient;\n   * Platelet count \\> 75,000\u002Fmm3 for B-cell NHL patient;\n   * B-ALL patients must have peripheral blast count ≤ 30,000\u002F mm3 prior to first dose of CC312.\n   * Prothrombin time-international normalized ratio (PT-INR) ≤ 1.5ULN.\n4. Female patients of childbearing potential or male patients with a partner of childbearing potential must use one or more contraception methods from screening and continued during study treatment until 3 months after the last dose;\n5. Ability to understand and willingness to provide written informed consent and to comply with scheduled visits and study procedures.\n\nExclusion Criteria:\n\n1. Systemic anticancer therapy within 5 half-lives of the agent or attending clinical trials 4 weeks prior to beginning CC312;\n2. Treatment with radiotherapy within 2 weeks before the study entry;\n3. Treatment with CAR-T within 3 months before the study entry;\n4. Active serious infection requiring antibiotics within 14 days before study entry;\n5. Patients with prior treatment with anti-CD19 directed therapies are eligible only if their tumor cells have been shown to express CD19 after completing the CD19-directed therapy;\n6. Patients with brain metastases or other significant neurological conditions, except for brain metastases which are asymptomatic and radiologically stable without need for steroids for 2 weeks before the first dose of CC312;\n7. Treatment with corticosteroids (\\>10mg daily prednisone or equivalent) or immunosuppressive medication ≤ 7 days before the first dose of CC312, with the following exceptions:\n\n   * Topical, ocular, intra-articular, intranasal, or inhalational corticosteroids;\n   * Use of dexamethasone to reduce peripheral blast counts in ALL;\n8. Vaccination with a live virus vaccine within 4 weeks prior to the study enrollment;\n9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement;\n10. Known to be allergic to protein drugs or recombinant proteins or excipients in the CC312 drug formulation. Patients who experienced Grade 3 reactions that lasted \\\u003C 24h may be eligible after discussion with investigator；\n11. Except for the tolerable events determined by the investigator, any toxic effects of the prior therapy which have not resolved to Grade 1 (CTCAE v5.0);\n12. Admission or evidence of illicit drug use, drug abuse, or alcohol abuse;\n13. Cerebrovascular accident (CVA), Transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) class III or IV heart failure occurring within \\\u003C6 months of study entry; uncontrolled arrhythmia within \\\u003C 3 months of study entry. Patients with rate-controlled arrhythmias may be eligible for study entry at discretion of the Investigator.;\n14. Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 2 weeks prior to screening; wound must be fully healed (minor surgical procedures such as catheter placement are not exclusionary criteria);\n15. Existence of congenital long QT syndrome, QTcF \\> 450 msec (for male) or 470 msec (for female), use of cardiac pacemaker, left ventricular ejection fraction (LVEF) \\\u003C50%, clinically significant arrhythmia that requires intervention, cardiac troponin I or T \\> 2.0 ULN, poorly controlled diabetes (HbA1c \\> 9%), hypertension (systolic pressure \\> 160 mmHg or diastolic pressure \\> 100mmHg), or other medical conditions as determined by the Investigator. Patients with stable atrial fibrillation or flutter are eligible for study entry at the discretion of the Investigator;\n16. Any other serious underlying medical (e.g. active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the Investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk for treatmentrelated complications;\n17. Concurrent malignancy \\\u003C 5 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or \\\u003C T1 urothelial carcinoma. Patients with prostate cancer that is under active surveillance are eligible.;\n18. Pregnant or nursing women.;\n19. Active hepatitis B：HBsAg positive and HBV-DNA\\>ULN; Active hepatitis C：HCV-Ab positive and HCV-RNA\\>ULN；\n20. Known HIV infection；\n21. B-NHL patient that received autologous stem cell transplant 6 months prior to study screening, or historically received organ or allogeneic stem cell\u002Fbone marrow transplant;\n22. B-ALL patients that received transplantation treatment within 3 months prior to enrollment in the study.;\n23. Subjects who in the judgement of the Investigator are not suited to participate in this trial.",{"count":51,"type":21},44,[53],"PHASE1","This is a Phase 1, open-label, dose-escalation study to evaluate the safety, PK, PD and immunogenicity of CC312 following intravenous doses of CC312 in patients with relapsed and refractory (r\u002Fr) CD19 expressing B-cell non-Hodgkin lymphoma and B-cell lymphocytic leukemia.",[56,57,58],"Non-hodgkin Lymphoma","Acute Lymphoblastic Leukaemia","Chronic Lymphocytic Leukemia","2025-09-17",{"date":61,"type":34},"2025-09-22",{"date":63,"type":34},"2023-08-07",{"date":65,"type":21},"2026-03",{"name":40,"class":41},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":42},"100584409","early-phase-1-safety-study-of-cc312-in-autoimmune-disease-patients-100584409","NCT06888960","Safety Study of CC312 in Autoimmune Disease Patients","An Exploratory Clinical Study on the Safety of CC312 in Treating Patients With Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects who fully understand the objectives, nature, methods of the study, and possible adverse reactions, voluntarily participate as subjects, and sign the informed consent form (ICF).\n* Age ≥18 years (inclusive, based on the time of signing ICF), male or female.\n* For SLE:\n\n  1. Subjects who are diagnosed with SLE according to the 2019 European League Against Rheumatism (EULAR)\u002F1997 American College of Rheumatology (ACR) diagnostic classification criteria;\n  2. SLEDAI-2000 score of ≥ 8 points and at least one BILAG grade A or two BILAG grade B under standard treatment conditions;\n  3. Meet one of the following conditions: antinuclear antibody (ANA) determined to be positive during the screening period, or anti-dsDNA antibodies higher than normal levels at screening, or anti-Sm antibodies higher than normal levels at screening;\n  4. Before the first dose of the investigational drug, subjects must have received at least one of the following standard treatments for 12 weeks, and the dose must have been stable for at least 30 days (dose reduction is allowed and dose increase is not allowed ). Standard treatment regimen refers to the stable use of any of the following (alone or in combination): a. Antimalarial (hydroxychloroquine) monotherapy; b. Antimalarials in combination with oral corticosteroids (OCS, e.g., prednisone or other hormones at equivalent doses) and\u002For immunosuppressants (including mycophenolate mofetil, cyclophosphamide, leflunomide, methotrexate, tacrolimus, ciclosporin, azathioprine, Tripterygium wilfordii); c. OCS and\u002For immunosuppressant combination therapy. If the subject is receiving OCS (e.g., prednisone or other hormones at equivalent doses), the following criteria must be met: at screening and during the screening period, the maximum dose of OCS is 30 mg\u002Fday of prednisone (or other hormones at equivalent doses); other drugs and traditional Chinese medicines that affect immunity may be continued at the discretion of the investigator.\n* For IIM:\n\n  1. According to the 2017 EULAR\u002FACR Classification Criteria, diagnosed as possible or definite IIM-possible IIM: with a score of 5.5 points without biopsy; definite IIM: with a score of 6.7 points with biopsy;\n  2. Meeting one of the following criteria: During or before the screening period, confirmed to have at least one positive myositis-specific autoantibody (MSA), myositis-associated autoantibody (MAA), or ANA;\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: the use of glucocorticoids (prednisone \\>1 mg\u002Fkg\u002Fd or equivalent dose) and\u002For at least one immunomodulatory drug: such as antimalarial drugs, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, tacrolimus, ciclosporin, and\u002For biological drug products: such as rituximab and belimumab.\n* For IIM:\n\n  1. Subjects who are diagnosed with SSc according to the 2013 EULAR\u002FACR diagnostic classification criteria;\n  2. Meets one of the following criteria: positive ANA confirmed during or before the screening period, or at least one positive SSc-related antibody profile (such as Scl70, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies);\n  3. Conventional treatment is ineffective or the disease relapses after remission. Conventional treatment is defined as: using glucocorticoids (prednisone \\> 0.5 mg\u002Fkg\u002Fd or equivalent dose) and cyclophosphamide, and any of the following immunomodulatory drugs: such as antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and\u002For biological agents: such as rituximab and belimumab, with a cumulative treatment duration \\> 6 months.\n* For RA:\n\n  1. Diagnosed with RA according to the 2010 EULAR\u002FACR diagnostic classification criteria;\n  2. Disease Activity Score DAS28-ESR \\>3.2 (i.e., moderate activity or higher) during the screening period;\n  3. Failure after treatment with at least one conventional disease-modifying antirheumatic drug (DMARD) and\u002For at least one targeted synthetic DMARD (tsDMARD)\u002Fbiologic DMARD (bDMARD) (defined as no remission after at least 3 months of treatment);\n  4. At screening, if the subject is taking prednisone or an equivalent dose of a glucocorticoid, the dose must be ≤10 mg\u002Fday and stable for at least 4 weeks before the first dose;\n  5. The subject must have discontinued traditional Chinese medicine for the treatment of RA for ≥4 weeks before the first dose;\n  6. Other DMARDs, except for methotrexate (MTX) (subjects who have been on routine MTX treatment for 12 weeks before enrollment, with a stable MTX dose for 4 weeks before enrollment), must meet the washout period requirements: discontinuation of conventional synthetic DMARDs (csDMARDs) (including but not limited to sulfasalazine, leflunomide, penicillamine, azathioprine, ciclosporin A, cyclophosphamide, hydroxychloroquine, etc.) and herbal agents (including Tripterygium wilfordii, total glucosides of paeony, sinomenine, etc.) for 4 weeks before the first dose; discontinuation of intra-articular, intramuscular, or intravenous corticosteroids for 4 weeks before the first dose; discontinuation of anakinra and etanercept for 4 weeks before the first dose; discontinuation of adalimumab and infliximab for 8 weeks before the first dose; discontinuation of golimumab, certolizumab pegol, and tocilizumab for 10 weeks before the first dose; discontinuation of abatacept for 12 weeks before the first dose; in addition, stable doses of nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted to be continued.\n* For ITP:\n\n  1. Diagnosed with ITP according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Adult Primary Immune Thrombocytopenia (2020 Edition);\n  2. Ineffective response or relapse after at least one prior treatment regimen (including but not limited to TPO mimetics\u002Fagonists, corticosteroids, immunoglobulins, azathioprine, cyclophosphamide, and\u002For rituximab);\n  3. At least 2 platelet count measurements (with an interval of more than 24 hours) from the screening period to before the first dose, with an average platelet count \\\u003C30×109\u002FLand no single platelet count\\>35×109\u002FL;\n  4. If receiving standard background therapy for ITP, the dose and frequency of this therapy should be stable for at least 4 weeks (dose change ≤10%) before the first dose.\n* For AIHA:\n\n  1. Diagnosed with AIHA according to the diagnostic criteria of the Chinese Guideline on the Diagnosis and Management of Autoimmune Haemolytic Anaemia (2022 Edition);\n  2. Poor response after at least first-line treatment (corticosteroids);\n  3. Presence of anaemia-related symptoms during the screening period;\n  4. The dose of supportive care must be stable for at least 4 weeks before the first dose.\n* Laboratory test results:\n\nComplete blood count:\n\n1. SLE, SSc, and IIM: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥60 g\u002FL, platelets ≥50 x109\u002FL;\n2. RA: Neutrophil count ≥1.5 x109\u002FL, haemoglobin ≥90 g\u002FL, platelets ≥100 x109\u002FL;\n3. ITP: Absolute neutrophil count ≥1.0 x109\u002FL, haemoglobin ≥70 g\u002FL, platelets ≥10 x109\u002FL;\n4. AIHA: Absolute neutrophil count ≥1.0 x109\u002FL, platelets ≥50 x109\u002FL (≥10 x109\u002FL for patients with Evans syndrome and transfusion is permitted).\n\nLiver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C3 times the upper limit of normal (ULN), and total serum bilirubin ≤1.5×ULN (≤3.0×ULN for Gilbert's syndrome) or if bilirubin abnormality is caused by the study disease, participation is allowed upon investigator's judgment.\n\nRenal function: For RA, ITP, and AIHA: Serum creatinine ≤1.5 times ULN, or calculated creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n\n* Left ventricular ejection fraction (LVEF) ≥50%.\n* Female subjects of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. Additionally, they must agree to refrain from collecting or donating eggs during this period; any male partners of reproductive potential must also agree to use effective contraceptive measures during this period.\n* Male subjects with reproductive potential must agree to use effective contraception from the screening period to 6 months after the last dose, and have no plans for reproduction or sperm donation. During this period, their female partners of childbearing potential must also agree to use effective contraception.\n\nExclusion Criteria:\n\n* Subjects who have severe lupus nephritis (defined as urinary protein \\>6 g\u002F24 h or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL), or required treatment of active nephritis with protocol-prohibited drugs, or required hemodialysis or received prednisone ≥100 mg\u002Fd or equivalent glucocorticoid therapy for ≥14 days within 8 weeks before screening.\n* Subjects who have central nervous system diseases caused by SLE or not caused by SLE within 8 weeks before screening (including but not limited to epilepsy, psychosis, posterior reversible encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.).\n* Other types of IIM: inclusion body myositis, diabetic amyotrophy, juvenile myositis; severe muscle injury or myositis causing permanent weakness or cardiac involvement due to non-IIM causes (e.g., stroke).\n* Pulmonary arterial hypertension associated with SSc requiring treatment; or rapidly progressive SSc-related lower gastrointestinal tract (small and large intestine) involvement (requiring parenteral nutrition), active antral vascular ectasia; previous renal crisis caused by SSc.\n* Significant organ transplantation (e.g., heart, lung, kidney, liver) or history of hematopoietic stem cell\u002Fbone marrow transplantation.\n* Concomitant presence of two or more immune diseases requiring systemic treatment, if the investigator deems the subject unsuitable for enrollment.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Have participated in any other clinical trials (including cell or gene therapy) within 4 weeks before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received CAR-T therapy within 6 months before screening.\n* Have received B-cell depleting drug rituximab or equivalent treatments (targeting CD19, CD20, BAFF, etc.) within 1 month before screening, unless it can be demonstrated that B cells have returned to pre-treatment levels or within the normal range.\n* Have received anti-SLE treatments (e.g., Saphnelo) other than standard therapy within 3 months before screening or within 5 half-lives of the investigational product (whichever is longer).\n* Have received a live\u002Fattenuated vaccine within 4 weeks before screening or plans to receive a live\u002Fattenuated vaccine during the study.\n* Active infection.\n* History of Grade 3-4 (CTCAE v5.0) allergic reaction to another monoclonal antibody treatment, or known allergy to any component or excipient of the CC312 drug product (including recombinant proteins, polysorbate 80, etc.); patients with a ≤Grade 3 allergy lasting \\\u003C24h may participate in this study after discussion with the investigator.\n* Acknowledgement of or evidence of illicit drug use, drug abuse, or alcoholism.\n* Subjects who have received major surgery within 4 weeks before screening or minor surgery within 2 weeks; wounds must be completely healed (surgical procedures such as catheter placement are not exclusion criteria).\n* History of any of the following cardiovascular diseases within 6 months before screening: NYHA Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant heart disease.\n* Any other serious underlying diseases (e.g., active gastric ulcer, uncontrolled seizures, cerebrovascular events, gastrointestinal bleeding, severe signs and symptoms of coagulation dysfunction, heart diseases), mental illnesses, psychological, familial, or endemic diseases that, in the investigator's judgment, may interfere with the planned staging, treatment, and follow-up; affect subjects; compliance; or expose the subjects to a higher risk of complications.\n* Evidence of concurrent malignant tumors within less than 5 years before screening, excluding adequately treated cervical carcinoma in situ, localized cutaneous squamous cell carcinoma, basal cell carcinoma, localized prostate cancer, ductal carcinoma in situ of the breast, or urothelial carcinoma of stage ≤T1. Subjects with prostate cancer undergoing active surveillance are eligible for this study.\n* Pregnant or breastfeeding women.\n* Subjects with positive results for viral serological tests during the screening period: positive for human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or Treponema pallidum antibody (TP-Ab).\n* Subjects with active or latent tuberculosis (positive T-SPOT) identified during the screening period.\n* History of splenectomy treatment within 6 months prior to screening.\n* ITP subjects: 1) Secondary immune thrombocytopenia secondary to SLE, chronic lymphocytic leukemia (CLL), immunodeficiency common variable (CVID), or antiphospholipid syndrome (APS); 2) Drug-induced thrombocytopenia; 3) Any bleeding event requiring treatment within 4 weeks prior to screening; 4) Within 2 weeks prior to screening, the subject has continuously used drug therapy that affects platelet function (including but not limited to aspirin, aspirin-containing compounds, clopidogrel, salicylates, and\u002For NSAIDs) for \\>3 days; 5) History of any arterial or venous thrombosis (stroke, transient ischaemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism), or clinical symptoms and medical history suggestive of thrombophilia; or any of the following: known arrhythmia that increases the risk of thrombotic events (e.g., atrial fibrillation), or corrected QT interval (QTc) \\>450 msec; or a history of other coagulation abnormalities.\n* ITP and AIHA subjects: Abnormal prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) that are considered clinically significant by the investigator.\n* Other subjects whom the investigator judges to be unsuitable for this study.",{"count":75,"type":21},18,[24],"This study is an open-label, multiple-dose escalation, Investigator-Initiated Trial (IIT) clinical trial designed to evaluate the safety and tolerability of CC312 in adult patients with relapsed and refractory autoimmune diseases. The trial also assesses pharmacokinetics (PK) and preliminary efficacy.\n\nCC312 is a trispecific T cell engager (TriTE) that targets the B cell surface antigen CD19, the T cell antigen CD3, and the T cell co-stimulatory molecule CD28. Given its mechanism of action, which is similar to the \"biopharmaceutical version\" of CAR-T, there is a higher risk of cytokine release syndrome (CRS) at the onset of infusion administration. Therefore, a lower priming dose will be administered before the therapeutic dosing phase to mitigate this risk and ensure safety, followed by a therapeutic dose to achieve and maintain efficacy.\n\nThe study is divided into three dose groups, with 3-6 subjects enrolled in each group, resulting in a total of 9-18 subjects in the study. A \"3+3\" dose escalation design is employed to systematically evaluate the safety and determine the optimal dose of CC312.",[79,80,81,82,83,84],"Systemic Lupus Erythematosus (SLE)","Idiopathic Inflammatory Myopathy (IIM)","Systemic Sclerosis (SSc)","Rheumatoid Arthritis (RA)","Primary Immune Thrombocytopenia (ITP)","Autoimmune Hemolytic Anemia","2025-09-11",{"date":59,"type":34},{"date":88,"type":34},"2024-11-08",{"date":90,"type":21},"2026-11-08",{"name":40,"class":41},{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":42},"100606619","phase-1-safety-and-efficacy-study-of-cc312-for-moderate-to-severe-sle-100606619","NCT07177911","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","Inclusion Criteria:\n\n* Fully understand the trial's purpose, nature, methodology, and potential adverse reactions, voluntarily participate as a subject, and sign the informed consent form.\n* Aged 18 to 65 years (inclusive, based on the date of signing the informed consent form), regardless of gender.\n* Diagnosed with systemic lupus erythematosus (SLE) according to the 2019 EULAR\u002FACR classification criteria.\n* SLEDAI-2000 score ≥7 with at least one BILAG A or two BILAG B domains, despite standard therapy.\n* 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.\n* 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\u002For biologic. Prior to the first dose, subjects must have been on a stable dose of corticosteroids (e.g., ≤40 mg\u002Fday prednisone or equivalent at screening and during the screening period; if used alone, ≥7.5 mg\u002Fday prednisone or equivalent) and\u002For antimalarials and\u002For immunosuppressants for at least 12 weeks, with doses stable for ≥30 days.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Severe lupus nephritis within 8 weeks prior to screening (defined as urinary protein \\>6 g\u002F24 h, or serum creatinine \\>2.5 mg\u002FdL or 221 μmol\u002FL, or requiring prohibited medications for active nephritis per protocol, or needing hemodialysis, or receiving prednisone ≥100 mg\u002Fd or equivalent glucocorticoids for ≥14 days).\n* 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.\n* History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell\u002Fbone marrow transplantation.\n* Other concurrent autoimmune diseases requiring systemic therapy, except for Sjögren's syndrome.\n* IgA deficiency (serum IgA level \\\u003C10 mg\u002FdL).\n* Abnormal laboratory findings at screening:\n\nLiver function: AST\u002FALT or total bilirubin \\>2× upper limit of normal (ULN); Hematology: hemoglobin \\\u003C85 g\u002FL, WBC \\\u003C2.5×10⁹\u002FL, neutrophil count \\\u003C1.0×10⁹\u002FL, platelet count \\\u003C50×10⁹\u002FL; Renal function: eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²;\n\n* 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).\n* Received CAR-T therapy within 6 months prior to screening.\n* Treatment with B-cell-depleting agents (e.g., rituximab, or therapies targeting CD19\u002FCD20\u002FBAFF) within 6 months prior to screening, unless B-cell levels have returned to pre-treatment or normal ranges.\n* 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.\n* Received live\u002Fattenuated vaccination within 4 weeks prior to screening or plans to receive such during the trial.\n* Active infection within 14 days prior to screening (bacterial, viral, fungal, parasitic, or other).\n* 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.\n* Evidence of drug abuse, substance abuse, or alcohol addiction.\n* 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).\n* History of cardiovascular events within 6 months prior to screening: NYHA Class III\u002FIV heart failure, myocardial infarction, unstable angina, uncontrolled\u002Fsymptomatic atrial arrhythmia, ventricular arrhythmia, or other clinically significant cardiac conditions.\n* 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.\n* Concurrent malignancy diagnosed within \\\u003C5 years prior to screening.\n* Grade ≥2 bleeding within 30 days prior to screening, or requiring long-term anticoagulants (e.g., warfarin, LMWH, factor Xa inhibitors).\n* Pregnant or lactating women.\n* Positive screening for: tuberculosis (PPD skin test or TB-IGRA, unless with prior adequate anti-TB treatment and no current signs), HIV antibody, HBsAg or HBcAb, HCV antibody, or TP antibody.\n* Any other condition deemed ineligible by the investigator.",{"count":100,"type":21},32,[53],"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).",[27],"2025-09-10",{"date":59,"type":34},{"date":85,"type":21},{"date":108,"type":21},"2027-09-10",{"name":40,"class":41},""]