A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
- 试验地点
- 32
- 主要终点
- Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
研究概览
简要总结
This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
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
- Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
- Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
- Must meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocol
- Measurable disease as defined by Lugano 2014 classification
- Eastern cooperative oncology group (ECOG) performance status of 0 to 2
排除标准
- History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
- History of stroke, unstable angina, myocardial infarction, congestive heart failure New York Heart Association (NYHA) Class III or IV, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of apheresis
- History of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder
- Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
- Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
- Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
- Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's Macroglobulinemia
- Any prior solid organ or allogeneic stem cell transplantation
- Autologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis
研究组 & 干预措施
JNJ-90014496
Participants will receive intravenous (IV) infusion of autologous JNJ-90014496. The study is no longer enrolling.
干预措施: JNJ-90014496 (Biological)
结局指标
主要结局
Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]
时间窗: Up to 15 Years post JNJ-90014496 infusion
Occurrence of any AEs, including dose limiting toxicities (DLTs).
Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)
时间窗: Up to 6 months post last participant's JNJ-90014496 infusion
Overall response is defined as a PR or CR at any point between the time of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).
次要结局
- Phase 1b: Overall Response (OR)(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 1b: Duration of Response (DOR)(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 1b: Pharmacokinetic Evaluation of JNJ-90014496(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Occurrence of Adverse Events (AEs) by Severity(Up to 15 Years post JNJ-90014496 infusion)
- Phase 2: Complete Response (CR)(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Duration of Response (DOR)(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Progression Free Survival (PFS)(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Overall Survival (OS)(Up to 15 Years post JNJ-90014496 infusion)
- Phase 2: Maximum Observed Blood Concentration (Cmax) for JNJ-90014496(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Time to Reach Maximum Observed Cmax (Tmax) for JNJ-90014496(Up to 6 months post last participant's JNJ-90014496 infusion)
- Phase 2: Area Under the Blood Concentration Time Curve (AUC) for JNJ-90014496(Up to 6 months post last participant's JNJ-90014496 infusion)
- Change From Baseline of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Symptom Score(From Baseline Up to 6 months post JNJ-90014496 infusion)
研究者
研究点 (32)
标识符
- NCT 编号
- NCT05421663
- 其他研究编号
- 90014496LYM1001, 2023-506267-33-00, 2023
日期
- 首次提交
- (4年前)
- 首次发布
- (4年前)
- 主要完成日期
- (14年后)
- 研究完成日期
- (14年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.