A Phase 1b Study of Bispecific T Cell Redirection Antibodies in Combination With Checkpoint Inhibition for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 74
- 试验地点
- 33
- 主要终点
- Number of Participants with Abnormalities in Clinical Laboratory Assessments
研究概览
简要总结
The purpose of the study is to identify the safe dose(s) of a PD-1 inhibitor in combination with talquetamab or teclistamab, and to characterize the safety and tolerability of talquetamab or teclistamab when administered in combination with a PD-1 inhibitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Have documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- •Participants with relapsed or refractory disease that are not a candidate for available therapy with established clinical benefit
- •Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); b) Urine M-protein level >= 200 milligrams (mg) per 24 hours; c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >= 10 milligrams/deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
排除标准
- •Prior antitumor therapy within 21 days prior to the first dose of study treatment (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene -modified adoptive cell therapy or autologous stem cell transplant within 3 months)
- •Prior therapy with PD-1 inhibitors, allogeneic stem cell transplant or solid organ transplant
- •Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- •Active Central Nervous System (CNS) involvement or exhibition of clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- •Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- •Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia [any grade] or peripheral neuropathy to Grade <= 2)
- •Received a cumulative dose of corticosteroids equivalent to >= 140 milligrams (mg) of prednisone within the 14-day period before the start of study treatment administration
研究组 & 干预措施
Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
干预措施: PD-1 Inhibitor (Drug)
Part 2: Dose Expansion
Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
干预措施: PD-1 Inhibitor (Drug)
Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
干预措施: Talquetamab (Drug)
Part 1: Dose Escalation
Participants will receive either talquetamab (treatment regimen A) or teclistamab (treatment regimen B) with a PD-1 inhibitor biweekly.
干预措施: Teclistamab (Drug)
Part 2: Dose Expansion
Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
干预措施: Teclistamab (Drug)
Part 2: Dose Expansion
Participants will receive either treatment regimen A or treatment regimen B with a PD-1 inhibitor at the dose levels identified in Part 1.
干预措施: Talquetamab (Drug)
结局指标
主要结局
Number of Participants with Abnormalities in Clinical Laboratory Assessments
时间窗: Up to 2 years 5 months
Number of participants with abnormalities in clinical laboratory assessments (serum chemistry and hematology) will be reported.
Number of Participants with Dose-Limiting Toxicity (DLTs)
时间窗: Up to 2 years 5 months
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Number of Participants with Adverse Events (AEs)
时间窗: Up to 2 years 5 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 2 years 5 months
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
次要结局
- Overall Response Rate (ORR)(Up to 2 years 5 months)
- Complete Response (CR) or Better Response Rate(Up to 2 years 5 months)
- Stringent Complete Response (sCR) Rate(Up to 2 years 5 months)
- Time to Response(Up to 2 years 5 months)
- Number of Participants with Anti-Teclistamab Antibodies(Up to 2 years 5 months)
- Serum Concentrations of Teclistamab(Up to 2 years 5 months)
- Number of Participants with Anti-PD-1 Inhibitor Antibodies(Up to 2 years 5 months)
- Very Good Partial Response (VGPR) or Better Response Rate(Up to 2 years 5 months)
- Duration of Response(Up to 2 years 5 months)
- Serum Concentrations of PD-1 Inhibitor(Up to 2 years 5 months)
- Serum Concentrations of Talquetamab(Up to 2 years 5 months)
- Number of Participants with Anti-Talquetamab Antibodies(Up to 2 years 5 months)