A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- ORR (Partial Response [PR] or Better)
研究概览
简要总结
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria;
- •Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy;
- •Measurable disease at screening, defined by at least one of the following:
- •Serum M-protein ≥1.0 g/dL (10 g/L);
- •Urine M-protein ≥200 mg/24 hours;
- •Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.
排除标准
- •History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy);
- •Prior anti-myeloma therapies within the specified timeframes before enrollment:
- •Previous treatment with GPRC5D-targeted therapy;
- •Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T], natural killer [NK] cell therapy) within 3 months;
- •Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer);
- •Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer);
- •Cytotoxic therapy or monoclonal antibodies within 21 days;
- •Proteasome inhibitor therapy within 14 days;
- •Immunomodulatory drug therapy within 7 days;
- •Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]);
- •Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
- •Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid);
- •Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);
- •Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab).
研究组 & 干预措施
QLS32015(SC) in combination with QL2109 or Daratumumab.
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: QLS32015 (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab.
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: QL2109 or Daratumumab (Drug)
QLS32015(SC) in combination with Pomalidomide
Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: Pomalidomide (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: Pomalidomide (Drug)
QLS32015(SC) in combination with Pomalidomide
Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: QLS32015 (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: QL2109 or Daratumumab (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: Dexamethasone (Drug)
QLS32015(SC) in combination with Pomalidomide
Participants will receive QLS32015 as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: Dexamethasone (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab.
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: Dexamethasone (Drug)
QLS32015(SC) in combination with QL2109 or Daratumumab and Pomalidomide
Participants will receive QLS32015 and QL2109 or Daratumumab as SC injections; Pomalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: QLS32015 (Drug)
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide
Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: QLS32015 (Drug)
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide
Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: Dexamethasone (Drug)
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide
Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: Bortezomib (Drug)
QLS32015(SC) in combination with Bortezomib for injection and Lenalidomide
Participants will receive QLS32015 and Bortezomib as SC injections; Lenalidomide will be self-administered as a single dose orally; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug
干预措施: Lenalidomide (Drug)
结局指标
主要结局
ORR (Partial Response [PR] or Better)
时间窗: Up to 2 years
Overall response (PR or better) is defined as percentage of participants who have a PR or better per International Myeloma Working Group (IMWG) criteria
Overall Minimal Residual Disease (MRD)
时间窗: Up to 2 years
MRD-negative is defined as proportion of participants who achieve MRD negativity at a threshold of 10\^-5 at any timepoint after the first dose of study drug and before disease progression or start of subsequent antimyeloma therapy
次要结局
- Progression-Free Survival (PFS)(Up to 2 years)