A Clinical Trial Evaluating SCB-219M in in Chemotherapy-induced Thrombocytopenia (CIT)

NCT05426369 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CLO-SCB-219M-CHN-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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)

Conditions

Chemotherapy-induced Thrombocytopenia (CIT)

Outcome Measures

Primary Outcomes (3)

• Dose escalation: Occurrence of DLT.

  Occurrence of DLT

  Occurrence of DLT from enrollment to day 21.

• Dose escalation: Frequency of DLT.

  Frequency of DLT

  Frequency of DLT from enrollment to day 21.

• Dose escalation and Dose expansion:Occurrence of AE.

  number, frequency,and charaterization of AEs

  28 days after the last administration of SCB-219M

Secondary Outcomes (18)

• Dose escalation: Cmax

  up to 21 days after treatment

• Dose escalation: Cmax/D

  up to 21 days after treatment

• Dose escalation: tmax

  up to 21 days after treatment

• Dose escalation: AUC0-24h

  up to 21 days after treatment

• Dose escalation: AUC0-last

  up to 21 days after treatment

Study Arms (3)

Dose Escalation

EXPERIMENTAL

For single dose escalation, the dose level will be 2µg/kg -15 µg/kg.

Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein

Dose Expansion - Group A: First-line CIT treatment / Prophylactic administration for CIT (as needed)

EXPERIMENTAL

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.

Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein

Dose Expansion - Group B: Previously treated or refractory CIT

EXPERIMENTAL

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.

Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein

Interventions

Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein BIOLOGICAL

Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein for injection (Strength: 1 mg/ml, 0.5ml/vial)

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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):
• \) 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)

Sponsors & Collaborators

• Sichuan Clover Biopharmaceuticals, Inc.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: June 22, 2022
• Study Start: June 14, 2022
• Primary Completion: July 2, 2025
• Study Completion: December 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

CN (1)