A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
- 试验地点
- 11
- 主要终点
- Number of Participants with Dose-limiting Toxicity (DLT)
研究概览
简要总结
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
- •Participants must have measurable disease as defined by the appropriate disease response criteria
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
- •Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
排除标准
- •Known active central nervous system involvement (CNS) or leptomeningeal involvement
- •Prior solid-organ transplantation
- •Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
- •Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
- •Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
- •Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
研究组 & 干预措施
JNJ-80948543
Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780.
干预措施: JNJ-75348780 (Drug)
JNJ-80948543
Participants will receive JNJ-80948543 in combination with JNJ-75348780 to determine the recommended phase 2 regimen (RP2R) in Part 1 (Dose escalation). JNJ-80948543 will be dosed in an escalation manner in combination with fixed doses of JNJ-75348780. In Part 2 (Dose expansion) participants will receive RP2R of JNJ-80948543 as determined in Part 1 in combination with JNJ-75348780.
干预措施: JNJ-80948543 (Drug)
结局指标
主要结局
Number of Participants with Dose-limiting Toxicity (DLT)
时间窗: Up to 1 year and 10 months
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for \>=7 days or Grade \>3 with Grade \>=2 bleeding; Grade 4 anemia).
Number of Participants with Adverse Events (AEs)
时间窗: Up to 1 year and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
次要结局
- Serum Concentration of JNJ-80948543 and JNJ-75348780(Up to 1 year and 10 months)
- Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780(Up to 1 year and 10 months)
- Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780(Up to 1 year and 10 months)
- Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780(Up to 1 year and 10 months)
- Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780(Up to 1 year and 10 months)
- Overall Response Rate (ORR)(Up to 1 year and 10 months)
- Complete Response Rate (CRR)(Up to 1 year and 10 months)
- Duration of Response (DoR)(Up to 1 year and 10 months)