NCT04557098进行中（未招募）2 期
TECLIMMY1001-P3: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 194
- 试验地点
- 71
- 主要终点
- Cohorts A and C: Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- •Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment
- •A female participant of childbearing potential must have a negative pregnancy test at screening
- •Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- •Cohort A: received at least >=3 prior lines of therapy and previously received a PI, an IMiD and an anti-CD38 monoclonal antibody; Cohort C: received >= 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)
排除标准
- •Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis
- •The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (<=) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction <= 6 m, stage III-IV congestive heart failure, etc)
- •Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3
- •Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug
- •Toxicities from previous anticancer therapies that have not resolved to baseline or to <= grade 1 (except for alopecia or peripheral neuropathy)
- •Received a cumulative dose of corticosteroids equivalent to >=140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)
- •Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)
- •Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence
- •Prior allogenic stem cell transplant <=6 months
- •Prior autologous stem cell transplant <=12 weeks
- •Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab
研究组 & 干预措施
Part 3: Teclistamab
Experimental
Participants will receive teclistamab subcutaneously (SC) at recommended Phase 2 dose (RP2D) in Cohort A and Cohort C.
干预措施: Teclistamab (Drug)
结局指标
主要结局
Cohorts A and C: Overall Response Rate (ORR)
时间窗: Up to 2.9 years
ORR is defined as the proportion of participants who have a partial response (PR) or better according to the International Myeloma Working Group (IMWG) criteria.
次要结局
- Cohorts A and C: Duration of Response (DOR)(Up to 2.9 years)
- Cohorts A and C: Very Good Partial Response (VGPR) or Better Rate(Up to 2.9 years)
- Cohorts A and C: Cohorts A and C: Complete Response (CR) or Better Rate(Up to 2.9 years)
- Cohorts A and C: Stringent Complete Response (sCR) Rate(Up to 2.9 years)
- Cohorts A and C: Time to Response (TTR)(Up to 2.9 years)
- Cohorts A and C: Progression-free Survival (PFS)(Up to 2.9 years)
- Cohorts A and C: Overall Survival (OS)(Up to 2.9 years)
- Cohorts A and C: Minimal Residual Disease (MRD) Negative Rate(Up to 2.9 years)
- Cohorts A and C: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Up to 2.9 years)
- Cohorts A and C: Number of Participants with Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability(Up to 2.9 years)
- Cohorts A and C: Number of Participants with AEs by Severity(Up to 2.9 years)
- Cohorts A and C: Number of Participants with Laboratory Abnormalities in Clinical Laboratory Values(Up to 2.9 years)
- Cohorts A and C: Serum Concentration of Teclistamab(Up to 3 months)
- Cohorts A and C: Number of Participants with Teclistamab Antibodies(Up to 2.9 years)
- Cohorts A and C: Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 item (EORTC QLQ-C30)(Baseline, up to 2.9 years)
- Cohorts A and C: Change from Baseline in HRQoL as Assessed by EuroQol Five Dimension Five Level Questionnaire (EQ-5D-5L)(Baseline, up to 2.9 years)
- Cohorts A and C: Change from Baseline in HRQoL as Assessed by Patient Global Impression of Severity (PGIS)(Baseline, up to 2.9 years)
- Cohorts A and C: Overall Response Rate (ORR) in Participants with High-risk Molecular Features(Up to 2.9 years)
研究者
研究点 (71)
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相关资讯
Teclistamab Shows Sustained Efficacy in Relapsed/Refractory Multiple Myeloma- Teclistamab demonstrates a 63% overall response rate in triple-class refractory multiple myeloma patients, including those with high-risk cytogenetics or extramedullary disease.
- A complete remission or better was achieved in 46% of patients, with a median duration of response reaching 24 months in the overall population treated with teclistamab.
- Cytokine release syndrome was a common adverse event, but infections were managed with prophylactic measures and IVIG, with a low discontinuation rate of 4.8%.
- The median progression-free survival was 11 months, and the median overall survival was 22 months, indicating a significant clinical benefit in a heavily pre-treated population.last yearAggressive Supportive Care May Reduce Infection Risk Following Linvoseltamab Treatment in Multiple Myeloma- Aggressive supportive care is crucial following linvoseltamab and BCMA bispecific antibody treatments to prevent high-grade infections, especially in community settings.
- Intravenous immunoglobulin and infection prophylaxis are essential components of supportive care to mitigate the risk of severe infections post-immunotherapy.
- Reducing the dosing frequency of bispecific antibodies, as seen with teclistamab, may also decrease the risk of infections over time.
- Phase 1/2 LINKER-MM1 trial data highlights the efficacy of linvoseltamab but also underscores the importance of managing treatment-related infection incidence.2 years ago