The ELiPSE-1 Study: A Phase 1, Multicenter, Open-Label Study of CNTY-101 in Subjects With Relapsed or Refractory CD19-Positive B-Cell Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 16
- 主要终点
- Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
研究概览
简要总结
ELiPSE-1 is a Phase 1, multi-center, dose-finding study to evaluate the safety, pharmacokinetics, and preliminary efficacy of CNTY-101 in participants with relapsed or refractory cluster of differentiation (CD)19-positive B-cell malignancies.
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
- •Diagnosis of CD19-positive relapsed or refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).
- •Must have met the following criteria for prior treatment:
- •Participants with aggressive NHL must have received at least 2 lines of systemic therapy (if not intended for transplant, have already undergone or be unwilling or unable to undergo chimeric antigen receptor [CAR] T-cell therapy to be eligible), or at least 3 lines of systemic therapy. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylator.
- •Participants with follicular lymphoma (FL) must have received at least 2 lines of systemic therapy and have high-risk disease. Previous therapy must have included a CD20-targeted agent and an alkylator.
- •Participants with marginal zone lymphoma (MZL) must have received at least 2 prior systemic therapies.
- •Measurable disease on screening evaluations.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function.
- •Life expectancy of ≥12 weeks.
排除标准
- •Any condition that confounds the ability to interpret data from the study.
- •Central nervous system (CNS)-only involvement by malignancy. (Note: participants with secondary CNS involvement are allowed.)
- •Prior allogeneic stem cell transplant.
- •Presence of clinically significant CNS pathology.
- •Other comorbid conditions defined in the protocol.
- •Use of prohibited medications within the washout period defined in the protocol.
研究组 & 干预措施
Dose Escalation: Schedule A
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
干预措施: CNTY-101 (Biological)
Dose Escalation: Schedule A
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
干预措施: IL-2 (Biological)
Dose Escalation: Schedule A
Lymphodepleting chemotherapy (LDC) will be followed by single dose administration of CNTY-101, alone or with supplemental human recombinant interleukin 2 (IL-2).
干预措施: Lymphodepleting Chemotherapy (Drug)
Dose Escalation: Schedule B
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
干预措施: CNTY-101 (Biological)
Dose Escalation: Schedule B
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
干预措施: IL-2 (Biological)
Dose Escalation: Schedule B
LDC will be followed by administration of CNTY-101, 3 times over 3 weeks, alone or with supplemental IL-2.
干预措施: Lymphodepleting Chemotherapy (Drug)
结局指标
主要结局
Recommended Phase 2 Regimen (RP2R) as Recommended by the Safety Review Committee (SRC)
时间窗: Up to 28 days
Maximum Tolerated Dose (MTD) as Determined by the Percentage of Participants With Dose Limiting Toxicities (DLTs) and DLTs Based on Severity
时间窗: Up to 28 days
次要结局
- Duration of Response (DOR)(Up to 2 years)
- Overall Survival (OS)(Day 1 up to 2 years)
- Percentage of Participants With at Least one Treatment Emergent Adverse Event (TEAE)(Day 1 up to 2 years)
- Time to Treatment Initiation(Enrollment to first CNTY-101 infusion (up to approximately 2 weeks))
- Progression-Free Survival (PFS)(Day 1 up to 2 years)
- Objective Response Rate (ORR) Based on Percentage of Participants Achieving CR or Partial Response (PR)(Up to 2 years)
- Complete Response Rate (CRR) Based on Percentage of Participants Achieving Complete Response (CR)(Up to 2 years)
- Cmax: Maximum Observed Plasma Concentration for CNTY-101(Day 1 up to 2 years)
- Percentage of Participants With Clinically Significant Laboratory Abnormalities(Day 1 up to 2 years)
- Time to Treatment Response (TTR)(Day 1 up to 2 years)
- Tmax: Time to Reach the Maximum Plasma Concentration for CNTY-101(Day 1 up to 2 years)
- t1/2: Terminal Disposition Phase Half-life for CNTY-101(Day 1 up to 2 years)
- AUC: Area under the Concentration-time Curve for CNTY-101(Day 1 up to 2 years)