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Clinical Trials in China / NCT07312188
Recruiting Phase 2

A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

NCT07312188 · tracked via the Priya Life Science China tracker
Sponsor
Shandong New Time Pharmaceutical Co., LTD
Phase
Phase 2
Started
2025-07-02
Last updated
2025-12-31

Condition(s) studied

Relapsed or Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

F182112+PF182112+CD38

F182112+P: F182112 + P

F182112+CD38: F182112+CD38

Study summary

This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Be diagnosed with multiple myeloma according to the IMWG 2016 criteria. * The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor. * Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled. * Have an ECOG performance status score of 0 - 2. * Meet at least one of the following measurable disease indicators: 1. Serum M - protein ≥ 5 g/L. 2. Urine M - protein ≥ 200 mg/24 h. 3. Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (\< 0.26 or \> 1.65). Exclusion Criteria: * Patients with primary light - chain amyloidosis or plasma cell leukemia . * Patients with symptoms of central nervous system involvement of multiple myeloma. * Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose. * Patients with active mucosal or visceral bleeding. * Patients who have previously received BCMA - targeted therapy.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Institute of Hematology & Blood Diseases Hospital Tianjin China Recruiting

More Shandong New Time Pharmaceutical Co., LTD trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07312188 on ClinicalTrials.gov ↗ ← All trials in China