A Multicenter, Open-Label Phase II Study to Evaluate QLS4131 Combination Therapy in the Treatment of Malignant Plasma Cell Neoplasms
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 162
- 主要终点
- DLT
研究概览
简要总结
The purpose of the study is to compare the efficacy of QLS4131(SC) in combination with QL2109, with or without pomalidomide or lenalidomide, and QLS4131 (SC) in combination with QL2109, and QLS4131 (SC) in combination with Pomalidomide, and QLS4131(SC) in combination with QL2109 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, or diagnosis of plasma cell leukemia and primary light-chain amyloidosis confirmed in accordance with relevant guidelines.;
- •For patients with multiple myeloma and plasma cell leukemia, measurable disease at screening is defined as meeting any one of the following:
- •Serum M-protein ≥0.5 g/dL (5 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.
- •For patients with light-chain amyloidosis:Measurable disease is defined as Involved serum free light chain ≥ 50 mg/L with an abnormal light chain ratio,ordifference between involved and uninvolved serum free light chains (dFLC) ≥ 50 mg/L.
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);
- •Patients who received any of the following prior anti-tumor therapies before the first dose of investigational productt:
- •Previous treatment with BCMA/GPRC5D/CD3-targeted therapy;
- •Received any anti-tumor therapy within 4 weeks prior to the first dose, except for the following circumstances:
- •Cytotoxic therapy or small-molecule targeted therapy within 2 weeks or 5 half-lives, If the half-life is unknown, the washout period shall be 2 weeks (whichever is longer);
- •Immunomodulatory drug therapy within 7 days
- •Genetically modified adoptive cell therapy within 3 months.;
- •Traditional Chinese medicine with anti-tumor indications within 14 days.;
- •Radiotherapy within 14 days
- •Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide);
- •Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide);
- •Prior intolerance to QL2109 (applies to treatment cohorts containing QL2109).
研究组 & 干预措施
QLS4131(SC) in combination with QL2109 for injection and Lenalidomide
Participants will receive QLS4131 and QL2109 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)
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide
Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ 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: QLS4131 (Drug)
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide
Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ 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: QL2109 (Drug)
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide
Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ 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: Pomalidomide (Drug)
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide
Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ 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)
QLS4131(SC) in combination with QL2109, with or without Pomalidomide or Lenalidomide
Participants will receive QLS4131 and QL2109 as SC injections; Pomalidomide/ 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)
QLS4131(SC) in combination with QL2109
Participants will receive QLS4131 and QL2109 as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: QLS4131 (Drug)
QLS4131(SC) in combination with QL2109
Participants will receive QLS4131 and QL2109 as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: QL2109 (Drug)
QLS4131(SC) in combination with QL2109
Participants will receive QLS4131 and QL2109 as SC injections; dexamethasone may be given orally or intravenously as a pretreatment medication and study drug.
干预措施: Dexamethasone (Drug)
QLS4131(SC) in combination with Pomalidomide
Participants will receive QLS4131 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: QLS4131 (Drug)
QLS4131(SC) in combination with Pomalidomide
Participants will receive QLS4131 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)
QLS4131(SC) in combination with Pomalidomide
Participants will receive QLS4131 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)
QLS4131(SC) in combination with QL2109 for injection and Lenalidomide
Participants will receive QLS4131 and QL2109 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: QLS4131 (Drug)
QLS4131(SC) in combination with QL2109 for injection and Lenalidomide
Participants will receive QLS4131 and QL2109 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: QL2109 (Drug)
QLS4131(SC) in combination with QL2109 for injection and Lenalidomide
Participants will receive QLS4131 and QL2109 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)
结局指标
主要结局
DLT
时间窗: From time of the first dose of QLS4131 to end of DLT period (28 days)
To evaluate the tolerability and safety of subcutaneous administration of QLS4131 for Injection in combination with other agents in patients with malignant plasma cell neoplasms
MTD
时间窗: Up to 2 years
To determine the maximum tolerated dose (MTD)
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
未报告次要终点