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Chemotherapy-induced Thrombocytopenia (CIT)Phase 1NCT05426369

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

A Phase 1 study testing Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein in people with Chemotherapy-induced Thrombocytopenia (CIT), run by Sichuan Clover Biopharmaceuticals, Inc. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
14 Jun 2022to Dec 2025
Phase
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • <!-- -->
  • PLT <75×10⁹/L during prior chemotherapy cycle;
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  • Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:
  • Group A (1st-line CIT prophylaxis/therapy):
  • <!-- -->
  • 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.
  • 7.Toxicity Resolution: Prior anti-tumor toxicity ≤ Grade 2 (CTCAE v5.0) at enrollment (alopecia/vitiligo/subjective symptoms excluded).
  • 8.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).
  • 12.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.

Who cannot join

  • 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
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  • 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.
  • 10.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).
  • 13.CNS Metastases: Active/untreated CNS or leptomeningeal metastases (asymptomatic brain metastases allowed).
  • 14.Uncontrolled Hypertension: Resting SBP ≥160 mmHg and/or DBP ≥100 mmHg (two measurements, 2h apart).
  • 15.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]).
  • 17.Concurrent Clinical Trials: Participation in other drug/device trials ≤4 weeks pre-dose or planned during study.
  • 18.Investigator's Discretion: Poor compliance or other factors deemed unsuitable for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

Other trials in China

About this study

Official title: 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

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)

Read the 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, and preliminarily observe and evaluate efficacy. The trial is divided into a dose escalation phase (Ia) and an expansion phase (Ib).

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

What participants receive

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

  • Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion ProteinBiological

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

Study groups in NCT05426369
Study groupRoleWhat they receive
Dose EscalationExperimentalFor single dose escalation, the dose level will be 2µg/kg -15 µg/kg.
Receives: 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)ExperimentalThe 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.
Receives: Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein
Dose Expansion - Group B: Previously treated or refractory CITExperimentalThe 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.
Receives: Biological: Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein

What is being measured

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

  1. Dose escalation: Occurrence of DLT.

    Occurrence of DLT

    Measured: Occurrence of DLT from enrollment to day 21.

  2. Dose escalation: Frequency of DLT.

    Frequency of DLT

    Measured: Frequency of DLT from enrollment to day 21.

  3. Dose escalation and Dose expansion:Occurrence of AE.

    number, frequency,and charaterization of AEs

    Measured: 28 days after the last administration of SCB-219M

Secondary outcomes (18)

  1. Dose escalation: Cmax

    Cmax : Maximum serum concentration

    Measured: up to 21 days after treatment

  2. Dose escalation: Cmax/D

    Cmax/D :Dose normalized Cmax

    Measured: up to 21 days after treatment

  3. Dose escalation: tmax

    tmax : Time to Cmax

    Measured: up to 21 days after treatment

  4. Dose escalation: AUC0-24h

    AUC0-24h: Area under the serum concentration-time curve from 0 h to 24 h

    Measured: up to 21 days after treatment

  5. Dose escalation: AUC0-last

    AUC0-last :Area under the serum concentration-time curve from 0 h on Day 1 to the last time point with a quantifiable concentration

    Measured: up to 21 days after treatment

  6. Dose escalation: AUC0-inf

    AUC0-inf : Area under the serum concentration-time curve from 0 h extrapolated to infinity

    Measured: up to 21 days after treatment

  7. Dose escalation: t1/2

    t1/2 : Apparent half-life

    Measured: up to 21 days after treatment

  8. Dose escalation: CL/F

    CL/F: Systemic clearance

    Measured: up to 21 days after treatment

  9. Dose escalation: Vz/F

    Vz/F: Volume of distribution

    Measured: up to 21 days after treatment

  10. Dose escalation: λz

    λz: Elimination rate constant

    Measured: up to 21 days after treatment

  11. Dose escalation: Preliminary efficacy assessment.The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.

    The percentage of subjects requiring platelet infusion and the frequency of infusion during the DLT observation period.

    Measured: up to 28 days after administration

  12. Dose escalation: Preliminary efficacy assessment.

    Duration of PLT count ≥50×10^9/L and percentage of subjects during the DLT observation period.

    Measured: up to 28 days after administration

  13. Dose escalation: Preliminary efficacy assessment.

    Duration of PLT count ≥75×10^9/L and percentage of subjects during the DLT observation period.

    Measured: up to 28 days after administration

  14. Dose escalation: Preliminary efficacy assessment.

    Duration of PLT count ≥100×10^9/L and percentage of subjects during the DLT observation period

    Measured: up to 28 days after administration

  15. Dose expansion:：PK parameters of SCB-219M were established after repeated abdominal subcutaneous injections.

    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.

    Measured: up to 168 hours after the last treatment

  16. Dose expansion: Preliminary efficacy assessment.

    Incidence of grade 2/3/4 thrombocytopenia (CTCAE version 5.0).

    Measured: 28 days after the last administration of SCB-219M

  17. Dose expansion: Preliminary efficacy assessment.

    Percentage of subjects requiring platelet transfusions and number of transfusions within 7, 14, 21, and 28 days post-dose

    Measured: Within 7, 14, 21, and 28 calendar days post-administration

  18. Dose expansion: ：Platelet response onset time (days), duration of platelet effect maintenance (days), and overall response rate (%).

    Key efficacy endpoints per protocol:

    1. Time (days) to first achievement of platelet counts ≥50×10⁹/L, ≥75×10⁹/L, and ≥100×10⁹/L post-dose ;;
    2. Duration (days) of sustained platelet count maintenance at or above prespecified thresholds (≥50×10⁹/L, ≥75×10⁹/L, ≥100×10⁹/L);
    3. Responder rate (%) , defined as the proportion of subjects achieving predefined platelet count thresholds.

    Measured: 28 days after the last administration of SCB-219M

Timeline

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

  1. First posted22 Jun 2022
  2. Study start14 Jun 2022
  3. Primary completion2 Jul 2025
  4. Study completionDec 2025 (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
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426369
Sponsor's protocol ID
CLO-SCB-219M-CHN-001
Status last verified
Jul 2025
First submitted
10 May 2022
Last updated
31 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant Human Tumor Necrosis Factor Receptor II -Fc-TPO Mimetic Peptide Fusion Protein in people with Chemotherapy-induced Thrombocytopenia (CIT), run by Sichuan Clover Biopharmaceuticals, 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 30 inclusion and 32 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2025. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose escalation: Occurrence of DLT. (time frame: Occurrence of DLT from enrollment to day 21.). The study lists 3 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 NCT05426369.

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 31 Jul 2025.

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