Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-12 @ 4:34 PM
Study NCT ID:
NCT05426369
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-31
First Post:
2022-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2022-06-15', 'lastUpdatePostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose escalation: Occurrence of DLT.', 'timeFrame': 'Occurrence of DLT from enrollment to day 21.', 'description': 'Occurrence of DLT'}, {'measure': 'Dose escalation: Frequency of DLT.', 'timeFrame': 'Frequency of DLT from enrollment to day 21.', 'description': 'Frequency of DLT'}, {'measure': 'Dose escalation and Dose expansion:Occurrence of AE.', 'timeFrame': '28 days after the last administration of SCB-219M', 'description': 'number, frequency,and charaterization of AEs'}], 'secondaryOutcomes': [{'measure': 'Dose escalation: Cmax', 'timeFrame': 'up to 21 days after treatment', 'description': 'Cmax : Maximum serum concentration'}, {'measure': 'Dose escalation: Cmax/D', 'timeFrame': 'up to 21 days after treatment', 'description': 'Cmax/D :Dose normalized Cmax'}, {'measure': 'Dose escalation: tmax', 'timeFrame': 'up to 21 days after treatment', 'description': 'tmax : Time to Cmax'}, {'measure': 'Dose escalation: AUC0-24h', 'timeFrame': 'up to 21 days after treatment', 'description': 'AUC0-24h: Area under the serum concentration-time curve from 0 h to 24 h'}, {'measure': 'Dose escalation: AUC0-last', 'timeFrame': 'up to 21 days after treatment', 'description': 'AUC0-last :Area under the serum concentration-time curve from 0 h on Day 1 to the last time point with a quantifiable concentration'}, {'measure': 'Dose escalation: AUC0-inf', 'timeFrame': 'up to 21 days after treatment', 'description': 'AUC0-inf : Area under the serum concentration-time curve from 0 h extrapolated to infinity'}, {'measure': 'Dose escalation: t1/2', 'timeFrame': 'up to 21 days after treatment', 'description': 't1/2 : Apparent half-life'}, {'measure': 'Dose escalation: CL/F', 'timeFrame': 'up to 21 days after treatment', 'description': 'CL/F: Systemic clearance'}, {'measure': 'Dose escalation: Vz/F', 'timeFrame': 'up to 21 days after treatment', 'description': 'Vz/F: Volume of distribution'}, {'measure': 'Dose escalation: λz', 'timeFrame': 'up to 21 days after treatment', 'description': 'λz: Elimination rate constant'}, {'measure': 'Dose escalation: Preliminary efficacy assessment.The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.', 'timeFrame': 'up to 28 days after administration', 'description': 'The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.'}, {'measure': 'Dose escalation: Preliminary efficacy assessment.', 'timeFrame': 'up to 28 days after administration', 'description': 'Duration of PLT count ≥50×10\\^9/L and percentage of subjects during the DLT observation period.'}, {'measure': 'Dose escalation: Preliminary efficacy assessment.', 'timeFrame': 'up to 28 days after administration', 'description': 'Duration of PLT count ≥75×10\\^9/L and percentage of subjects during the DLT observation period.'}, {'measure': 'Dose escalation: Preliminary efficacy assessment.', 'timeFrame': 'up to 28 days after administration', 'description': 'Duration of PLT count ≥100×10\\^9/L and percentage of subjects during the DLT observation period'}, {'measure': 'Dose expansion:：PK parameters of SCB-219M were established after repeated abdominal subcutaneous injections.', 'timeFrame': 'up to 168 hours after the last treatment', 'description': 'The PK parameters include: C₀, Cmax/D, Css\\_min, Cmax\\_ss, Cav\\_ss, Rac, tmax, AUC₀-last, AUC₀-inf, AUCss, DF, MRT, t₁/₂, etc.'}, {'measure': 'Dose expansion: Preliminary efficacy assessment.', 'timeFrame': '28 days after the last administration of SCB-219M', 'description': 'Incidence of grade 2/3/4 thrombocytopenia (CTCAE version 5.0).'}, {'measure': 'Dose expansion: Preliminary efficacy assessment.', 'timeFrame': 'Within 7, 14, 21, and 28 calendar days post-administration', 'description': 'Percentage of subjects requiring platelet transfusions and number of transfusions within 7, 14, 21, and 28 days post-dose'}, {'measure': 'Dose expansion: ：Platelet response onset time (days), duration of platelet effect maintenance (days), and overall response rate (%).', 'timeFrame': '28 days after the last administration of SCB-219M', 'description': 'Key efficacy endpoints per protocol:\n\n1. Time (days) to first achievement of platelet counts ≥50×10⁹/L, ≥75×10⁹/L, and ≥100×10⁹/L post-dose ;;\n2. Duration (days) of sustained platelet count maintenance at or above prespecified thresholds (≥50×10⁹/L, ≥75×10⁹/L, ≥100×10⁹/L);\n3. Responder rate (%) , defined as the proportion of subjects achieving predefined platelet count thresholds.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Thrombocytopenia (CIT)']}, 'descriptionModule': {'briefSummary': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the patients with chemotherapy-induced thrombocytopenia (CIT)', 'detailedDescription': 'The purpose of this trial is to evaluate the safety, tolerability, immunogenicity, and PK characteristics of single and multiple subcutaneous injections of SCB-219M for CIT, explore the MTD and BED, and preliminarily observe and evaluate efficacy. The trial is divided into a dose escalation phase (Ia) and an expansion phase (Ib).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 18-75 years (inclusive), voluntary participation with signed informed consent and commitment to protocol-defined visits.\n2. Body Weight: ≥40 kg.\n3. Diagnosis: Histopathologically/cytopathologically confirmed malignant solid tumors or lymphoma.\n4. Phase Ia: Platelet (PLT) \\& Treatment Status:\n\n<!-- -->\n\n1. PLT \\<75×10⁹/L during prior chemotherapy cycle;\n2. Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:\n\n * Group A (1st-line CIT prophylaxis/therapy):\n\n<!-- -->\n\n1. PLT \\<50×10⁹/L, or\n2. PLT 50-75×10⁹/L. • Group B (2nd-line CIT therapy/refractory cases): Second-line CIT treatment for refractory or treated CIT patients who failed first-line therapy (rhTPO/IL-11) with platelet count \\<50×10⁹/L 6.Refractory/Treated CIT Definition:\n\n * Platelet count remains \\<50×10⁹/L or increases by \\<20×10⁹/L within 14 days after completing first-line CIT therapy (e.g., rhTPO or rhIL-11), with baseline PLT \\<50×10⁹/L at enrollment.\n\n 7.Toxicity Resolution: Prior anti-tumor toxicity ≤ Grade 2 (CTCAE v5.0) at enrollment (alopecia/vitiligo/subjective symptoms excluded).\n\n 8.ECOG PS: 0-2. 9.Life Expectancy: ≥3 months (investigator-assessed). 10.Baseline Laboratory (Pre-dose):\n * a) Creatinine ≤1.5×ULN; CrCl \\>40 mL/min;\n * b) PT/APTT/INR 80-120% of normal range;\n * c) ANC ≥1.5×10⁹/L;\n * d) Hemoglobin ≥70 g/L;\n * e) Albumin ≥25 g/L. 11.Liver Function:\n * a) ALT/AST ≤3×ULN (≤5×ULN if liver metastasis);\n * b) Total bilirubin ≤2.0×ULN (Gilbert's syndrome/asymptomatic cholelithiasis exempted).\n\n 12.Contraception:\n * Fertile subjects must use ≥1 method:\n\n o Absolute abstinence;\n * Double-barrier (condom + spermicidal diaphragm);\n * IUD/hormonal contraceptives (oral/implant/patch/injection);\n * Hysterectomy/bilateral salpingectomy/tubal ligation (females or partners);\n * Vasectomy/azoospermia (males or partners).\n * Females: Negative serum β-HCG within 28 days;\n * Males: No sperm donation from first dose to 180 days post-last dose.\n\nExclusion Criteria:\n\n1. Pregnancy/Lactation: Pregnant or breastfeeding females.\n2. Hypersensitivity: Known allergy to protein-based drugs (e.g., recombinant proteins, mAbs) or excipients of the investigational product.\n3. Active Infection: Acute infection requiring IV antibiotics without clinical control.\n4. Prior Thrombopoietic Agents:\n\n • Group A: Use within specified windows pre-SCB-219M:\n\n o Trilaciclib: ≤3 weeks\n\n o Romiplostim: ≤2 weeks\n\n o TPO-RAs (e.g., eltrombopag), rhTPO, IL-11, or platelet transfusion: ≤10 days\n\n • Group B: Use within:\n\n o Romiplostim/rhTPO/IL-11: ≤7 days\n\n o TPO-RAs/platelet transfusion: ≤3 days\n5. Anticoagulant Use: Anticoagulants/antiplatelet drugs ≤5 half-lives pre-dose or needed during study (aspirin washout ≥7 days).\n6. Non-Chemotherapy Thrombocytopenia (within 6 months/unresolved):\n\n1\\) Clinically significant non-chemotherapy-induced thrombocytopenia (e.g., EDTA-dependent pseudothrombocytopenia) 2) Hematologic malignancies (excluding lymphoma; e.g., leukemia) 3) Multiple myeloma 7.Bleeding Events (within 2 weeks pre-screening):\n\n• Group A: ≥Grade 2 (WHO Bleeding Scale)\n\n* Group B: ≥Grade 3 (WHO Bleeding Scale) 8.Non-CIT Thrombocytopenia Etiologies: 1) Primary immune thrombocytopenia (pITP) 2) Bone marrow failure (e.g., aplastic anemia, Fanconi anemia) 3) Myeloproliferative disorders/MDS 4) Hypersplenism secondary to hematologic/autoimmune diseases 9.Splenectomy/Splenic Effects: Splenic metastasis affecting hematopoiesis; splenectomy/splenic artery embolization ≤12 weeks pre-enrollment.\n\n 10.Uncontrolled Cardiovascular Disease:\n* NYHA Class III/IV heart failure\n* Pro-thrombotic conditions (e.g., atrial fibrillation, unstable angina)\n* QTc \\>470 ms (\\>480 ms with bundle branch block)\n* Myocardial infarction ≤6 months (Note: Pacemaker/ICD users with normal function eligible) 11.Thrombotic/Coagulation Disorders:\n* Coagulopathies\n* Arterial/venous thrombosis ≤3 months (excluding PICC-related thrombosis)\n* Transient ischemic attack ≤3 months 12.Major Procedures/Radiotherapy: Major surgery/radiotherapy ≤4 weeks pre-dose (except toxicity ≤Grade 2 \\[CTCAE v5.0\\], alopecia/vitiligo permitted).\n\n 13.CNS Metastases: Active/untreated CNS or leptomeningeal metastases (asymptomatic brain metastases allowed).\n\n 14.Uncontrolled Hypertension: Resting SBP ≥160 mmHg and/or DBP ≥100 mmHg (two measurements, 2h apart).\n\n 15.Active Infections:\n* HIV seropositivity\n* Active HBV (HBsAg+ andHBV DNA \\>LLOQ)\n* Active HCV (anti-HCV+ andHCV RNA \\>LLOQ) 16.Live Vaccines: Live attenuated vaccines ≤4 weeks pre-dose (COVID-19 vaccines permitted except Ad5-vectored type \\[requires investigator assessment\\]).\n\n 17.Concurrent Clinical Trials: Participation in other drug/device trials ≤4 weeks pre-dose or planned during study.\n\n 18.Investigator's Discretion: Poor compliance or other factors deemed unsuitable for the study."}, 'identificationModule': {'nctId': 'NCT05426369', 'briefTitle': 'A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sichuan Clover Biopharmaceuticals, Inc.'}, 'officialTitle': 'A Phase I Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Preliminary Efficacy and Pharmacokinetics of SCB-219M in the Patients With Chemotherapy-induced Thrombocytopenia', 'orgStudyIdInfo': {'id': 'CLO-SCB-219M-CHN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation', 'description': 'For single dose escalation, the dose level will be 2µg/kg -15 µg/kg.', 'interventionNames': ['Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion - Group A: First-line CIT treatment / Prophylactic administration for CIT (as needed)', 'description': 'The dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly (group A) , with a total of no more than 4 administrations within 70 days after the first dose.', 'interventionNames': ['Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion - Group B: Previously treated or refractory CIT', 'description': 'The dose level is recommended to be the bioeffective dose obtained from dose escalation and administered once weekly ( group B ), with a total of no more than 4 administrations within 70 days after the first dose.', 'interventionNames': ['Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein']}], 'interventions': [{'name': 'Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein', 'type': 'BIOLOGICAL', 'description': 'Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion - Group A: First-line CIT treatment / Prophylactic administration for CIT (as needed)', 'Dose Expansion - Group B: Previously treated or refractory CIT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan Clover Biopharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}