NCT07134088进行中（未招募）1 期
A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants With Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen
- 入组人数
- 104
- 试验地点
- 5
- 主要终点
- Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
研究概览
简要总结
The main objective of this study is to evaluate the safety and efficacy of SC blinatumomab in children below 12 years of age.
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
- 28 Days 至 4383 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥28 days to <12 years at the time of informed consent/assent.
- •Lansky Performance Status (LPS) of ≥ 50%.
- •For Phase 1b and Phase 2 cohort in participants with R/R B-ALL:
- •Participants with B-ALL relapsed after or refractory to any line of treatment including allogeneic hematopoietic stem cell transplant (HSCT).
- •Greater than or equal to 5% blasts in the bone marrow (BM) is considered as relapse in the BM.
- •For Phase 2 cohort in participants with MRD+ B-ALL:
- •Participants with MRD+ B-ALL must have between ≥ 0.1% and < 5% blasts in the BM.
- •Prior CD19-directed therapy will be allowed (with demonstrated continued CD19+ expression) if treatment ended >4 weeks prior to start of protocol therapy and no prior central nervous system (CNS) complications.
- •Any Philadelphia chromosome-positive (Ph+) participant intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.
排除标准
- •Active ALL in the CNS.
- •History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood seizure, paresis, aphasia, stroke, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis, or severe (≥ grade 3) CNS events including immune effector cell-associated neurologic syndrome (ICANS) from prior CAR-T or other T-cell engager therapies.
- •Isolated EM disease.
- •Current autoimmune disease or history of autoimmune disease with potential CNS involvement.
- •Patients with Down Syndrome are not eligible for this study.
- •Active acute or chronic graft versus host disease requiring systemic treatment with immunosuppressive medication.
- •Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus.
- •Presence of an acute or uncontrolled chronic infection, or any other concurrent disease or medical condition that could be worsened by the treatment or interfere with the participant's ability to comply with the study protocol.
- •Allogeneic HSCT within 12 weeks before the start of blinatumomab.
研究组 & 干预措施
Phase 1b: R/R B-ALL
Experimental
Participants with R/R B-ALL will receive blinatumomab as SC injection to determine the pediatric recommended Phase 2 dose (RP2D).
干预措施: Blinatumomab (Drug)
Cohort Ph2-R
Experimental
Participants with R/R B-ALL will receive blinatumomab as SC injection at RP2D.
干预措施: Blinatumomab (Drug)
Cohort Ph2-M
Experimental
Participants with MRD+ B-ALL will receive blinatumomab as SC injection at RP2D.
干预措施: Blinatumomab (Drug)
结局指标
主要结局
Phase 1b: Number of Participants who Experienced Dose Limiting Toxicities (DLTs)
时间窗: Up to 29 days
Phase 1b: Number of Participants who Experienced Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced Serious TEAEs
时间窗: Up to 2 years and 7 months
Phase 1b: Number of Participants who Experienced Treatment-related TEAEs
时间窗: Up to approximately 7 months
Phase 1b: Number of Participants who Experienced AEs of Interest (EOI)
时间窗: Up to approximately 7 months
Phase 2; R Cohort: Number of Participants who had Complete Remission/Complete Remission with Partial Hematological Recovery (CR/CRh) Within the First 2 Cycles
时间窗: Up to 70 days
Phase 2; M Cohort: Number of Participants who had CR with MRD Negative Response Within the First 2 Cycles
时间窗: Up to 70 days
MRD negative response = MRD level \< 10\^-4 (0.01%).
次要结局
- Phase 1b: Number of Participants who had CR/CRh Within the First 2 Cycles(Up to 70 days)
- Phase 1b: Number of Participants who had CR Within the First 2 Cycles(Up to 70 days)
- Phase 1b: Number of Participants who had CR/CRh/Complete Remission with Incomplete Hematological Recovery (CRi) or Blast Free Hypoplastic or Aplastic Bone Marrow (BM) Within the First 2 Cycles(Up to 70 days)
- Phase 1b: Number of Participants with a MRD Negative Response Within the First 2 Cycles(Up to 70 days)
- Phase 1b: Duration of Response (DOR)(Up to 2 years and 7 months)
- Phase 1b: Maximum Concentration (Cmax) of Blinatumomab(Up to approximately 7 months)
- Phase 1b: Time to Maximum Concentration (Tmax)(Up to approximately 7 months)
- Phase 1b: Area Under the Concentration Time Curve (AUC)(Up to approximately 7 months)
- Phase 1b: Number of Participants with Anti-blinatumomab Antibodies(Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days))
- Phase 2: Number of Participants who had CR/CRh with MRD Negative Response Within the First 2 Cycles(Up to 70 days)
- Phase 2: DOR(Up to 2 years and 7 months)
- Phase 2; R Cohort: Number of participants who had CR Within the First 2 Cycles(Up to 70 days)
- Phase 2; R Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM Within the First 2 Cycles(Up to 70 days)
- Phase 2: Overall Survival (OS)(Up to 2 years and 7 months)
- Phase 2: Number of Participants who Experienced TEAEs, Serious TEAEs, Treatment Related TEAEs and EOIs(Up to 2 years and 7 months)
- Phase 2: Blinatumomab Serum Concentrations(Up to 175 days)
- Phase 2: Number of Participants with Anti-blinatumomab Antibodies(Cycle 1, Day 1 and Cycle 2, Day 1 (Cycle Duration = 35 days))
- Phase 2; M Cohort: Number of participants who had CR/CRh/CRi and Blast Free Hypoplastic or Aplastic BM with MRD Negative Response Within the First 2 Cycles(Up to 70 days)
研究者
研究点 (5)
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