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Recruiting Phase 3

A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

NCT06508983 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-06-14
Last updated
2026-07-10

Condition(s) studied

Relapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

SG301 Injection →SG301 placebopomalidomide →dexamethasone →

SG301 Injection: Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

SG301 placebo: Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.

pomalidomide: Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.

dexamethasone: Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \< 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.

Study summary

The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Males and females aged 18-75 years (inclusive) 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2 4. Expected survival time of ≥3 months. 5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease. 6. Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination. 7. Subjects must have documented evidence of PD on or after the last regimen. 8. Adequate function of vital organs 9. Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment. Exclusion Criteria: 1. Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course. 2. Bone independent extramedullary disease at screening. 3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy. 4. Previous exposure to pomalidomide. 5. Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; 6. Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; 7. Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment; 8. Active hepatitis B, or C. 9. Known HIV infection. 10. Known active tuberculosis or positive treponema pallidum antibodies. 11. Subjects with clinical significant organ dysfunction that does not meet the study needs. 12. Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment. 13. Known allergy to any component of the investigational medicinal product. 14. Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.

Primary outcome measure(s)

  • Adverse events (stage 1) — From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
    AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
  • Recommended stage 2 dose of SG301 (Stage 1) — Up to approximately 6 months.
    Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data
  • Progression Free Survival (Stage 2) — From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
    Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).

Trial sites (12)

FacilityCityRegionStatus
Beijing Chaoyang Hospital of Capital Medical University Beijing Beijing Municipality Recruiting
Guangzhou First People's Hospital Guangzhou Guangdong Not Yet Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Henan Cancer Hospital Zhengzhou Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
The First Affiliated Hospital Of Soochow University Suzhou Jiangsu Recruiting
Shanxi Provincial Hospital Taiyuan Shanxi Recruiting
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital) Xi’an Shanxi Recruiting
Tianjin Cancer University Airport Hospital Tianjin Tianjin Municipality Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Not Yet Recruiting
The Second Affiliated Hospital Zhejiang University School Of Medicine Hangzhou Zhejiang Recruiting
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 NCT06508983 on ClinicalTrials.gov ↗ ← All trials in China