Status:
ACTIVE_NOT_RECRUITING
A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)
Lead Sponsor:
Sichuan Clover Biopharmaceuticals, Inc.
Conditions:
Chemotherapy-induced Thrombocytopenia (CIT)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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)
Detailed Description
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, a...
Eligibility Criteria
Inclusion
- Age: 18-75 years (inclusive), voluntary participation with signed informed consent and commitment to protocol-defined visits.
- Body Weight: ≥40 kg.
- Diagnosis: Histopathologically/cytopathologically confirmed malignant solid tumors or lymphoma.
- Phase Ia: Platelet (PLT) \& Treatment Status:
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- PLT \<75×10⁹/L during prior chemotherapy cycle;
- Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:
- Group A (1st-line CIT prophylaxis/therapy):
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- PLT \<50×10⁹/L, or
- 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:
- 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.
- Toxicity Resolution: Prior anti-tumor toxicity ≤ Grade 2 (CTCAE v5.0) at enrollment (alopecia/vitiligo/subjective symptoms excluded).
- ECOG PS: 0-2. 9.Life Expectancy: ≥3 months (investigator-assessed). 10.Baseline Laboratory (Pre-dose):
- a) Creatinine ≤1.5×ULN; CrCl \>40 mL/min;
- b) PT/APTT/INR 80-120% of normal range;
- c) ANC ≥1.5×10⁹/L;
- d) Hemoglobin ≥70 g/L;
- e) Albumin ≥25 g/L. 11.Liver Function:
- a) ALT/AST ≤3×ULN (≤5×ULN if liver metastasis);
- b) Total bilirubin ≤2.0×ULN (Gilbert's syndrome/asymptomatic cholelithiasis exempted).
- Contraception:
- Fertile subjects must use ≥1 method:
- o Absolute abstinence;
- Double-barrier (condom + spermicidal diaphragm);
- IUD/hormonal contraceptives (oral/implant/patch/injection);
- Hysterectomy/bilateral salpingectomy/tubal ligation (females or partners);
- Vasectomy/azoospermia (males or partners).
- Females: Negative serum β-HCG within 28 days;
- Males: No sperm donation from first dose to 180 days post-last dose.
Exclusion
- Pregnancy/Lactation: Pregnant or breastfeeding females.
- Hypersensitivity: Known allergy to protein-based drugs (e.g., recombinant proteins, mAbs) or excipients of the investigational product.
- Active Infection: Acute infection requiring IV antibiotics without clinical control.
- Prior Thrombopoietic Agents:
- • Group A: Use within specified windows pre-SCB-219M:
- o Trilaciclib: ≤3 weeks
- o Romiplostim: ≤2 weeks
- o TPO-RAs (e.g., eltrombopag), rhTPO, IL-11, or platelet transfusion: ≤10 days
- • Group B: Use within:
- o Romiplostim/rhTPO/IL-11: ≤7 days
- o TPO-RAs/platelet transfusion: ≤3 days
- Anticoagulant Use: Anticoagulants/antiplatelet drugs ≤5 half-lives pre-dose or needed during study (aspirin washout ≥7 days).
- Non-Chemotherapy Thrombocytopenia (within 6 months/unresolved):
- 1\) 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):
- • Group A: ≥Grade 2 (WHO Bleeding Scale)
- 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.
- Uncontrolled Cardiovascular Disease:
- NYHA Class III/IV heart failure
- Pro-thrombotic conditions (e.g., atrial fibrillation, unstable angina)
- QTc \>470 ms (\>480 ms with bundle branch block)
- Myocardial infarction ≤6 months (Note: Pacemaker/ICD users with normal function eligible) 11.Thrombotic/Coagulation Disorders:
- Coagulopathies
- Arterial/venous thrombosis ≤3 months (excluding PICC-related thrombosis)
- 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).
- CNS Metastases: Active/untreated CNS or leptomeningeal metastases (asymptomatic brain metastases allowed).
- Uncontrolled Hypertension: Resting SBP ≥160 mmHg and/or DBP ≥100 mmHg (two measurements, 2h apart).
- Active Infections:
- HIV seropositivity
- Active HBV (HBsAg+ andHBV DNA \>LLOQ)
- 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 \[requires investigator assessment\]).
- Concurrent Clinical Trials: Participation in other drug/device trials ≤4 weeks pre-dose or planned during study.
- Investigator's Discretion: Poor compliance or other factors deemed unsuitable for the study.
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05426369
Start Date
June 14 2022
End Date
December 1 2025
Last Update
July 31 2025
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China