Active — Not RecruitingPhase 1

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

China36 participantsStarted 2022-06-14

Plain-language 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)

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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;
✓. Receiving mono/combination chemotherapy (may include targeted/immunotherapy). 5.Phase Ib: Stratified Requirements:
✓. 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:

Exclusion criteria

✕. 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:
✕

What they're measuring

Dose escalation: Occurrence of DLT.

Timeframe: Occurrence of DLT from enrollment to day 21.

Dose escalation: Frequency of DLT.

Timeframe: Frequency of DLT from enrollment to day 21.

Dose escalation and Dose expansion:Occurrence of AE.

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

Trial details

NCT IDNCT05426369

SponsorSichuan Clover Biopharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-02

View on ClinicalTrials.gov More Chemotherapy-induced Thrombocytopenia (CIT) trials