NCT05652335招募中1 期
Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 53
- 主要终点
- Part 2: Number of Participants with Abnormalities in Laboratory Values
研究概览
简要总结
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
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
- •For participants with relapsed or refractory multiple myeloma:
- •Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- •Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy
- •Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- •Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level >=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging [MRI] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)
- •For participants with previously treated AL amyloidosis:
- •Initial histopathological diagnosis of amyloidosis
- •Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis
- •Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) >=50 mg/L or difference between involved and uninvolved free light chains (dFLC) >=50 mg/L, or serum m-protein >= 0.5 g/dL
- •One or more organs impacted by systemic AL amyloidosis
- •Left ventricular ejection fraction (LVEF) >=45%
排除标准
- •For participants with relapsed or refractory multiple myeloma:
- •Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required
- •Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- •Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mg of prednisone within the 14-day period before the start of study treatment administration
- •Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days [not applicable for Part 2C participants], or CD3-redirecting therapy within 21 days[not applicable for Part 2B or 2C participants])
- •Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- •Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- •Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
- •The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction <=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)
- •Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration
- •For participants with previously treated AL amyloidosis:
- •CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required
- •Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
- •Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- •Pulmonary compromise requiring supplemental oxygen use
- •Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions
- •Previous or current diagnosis of symptomatic multiple myeloma
- •Macroglossia that impairs swallowing difficulty
- •Received a cumulative dose of corticosteroids equivalent to > 140 mg of prednisone within the 14-day period before the start of study treatment administration
- •Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)
- •Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration
- •Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- •Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)
研究组 & 干预措施
Part 1: Dose Escalation
Experimental
Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.
干预措施: JNJ-79635322 (Drug)
Part 2: Dose Expansion
Experimental
Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.
干预措施: JNJ-79635322 (Drug)
结局指标
主要结局
Part 2: Number of Participants with Abnormalities in Laboratory Values
时间窗: Up to 2 Years 5 months
Number of participants with abnormalities in laboratory values (hematology and chemistry) will be reported.
Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity
时间窗: Up to 2 years 5 months
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Part 1: Number of Participants with Dose-limiting Toxicity (DLT)
时间窗: Up to 2 years 5 months
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
次要结局
- Duration of Response (DOR) as Defined by IMWG 2016 Response Criteria(Up to 2 Years 5 months)
- Part 2: Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)
- Serum Concentration of JNJ-79635322(Up to 2 Years 5 months)
- Time to Response (TTR) as Defined by IMWG 2016 Response Criteria(Up to 2 Years 5 months)
- Number of Participants with Presence of Anti-Drug Antibodies to JNJ-79635322(Up to 2 Years 5 months)
- Preliminary Anticancer Activity of JNJ-79635322 as Defined by International Myeloma Working Group (IMWG) 2016 Response Criteria(Up to 2 Years 5 months)
- Part 2: Duration of Response (DOR) as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)
- Part 2: Time to Response (TTR) as Defined by International Amyloidosis Consensus Criteria(Up to 2 Years 5 months)
研究者
研究点 (53)
Loading locations...
相似试验
已完成
1 期
A Study of JNJ-63898081 in Participants With Advanced Stage Solid TumorsNeoplasmsNCT03926013Janssen Research & Development, LLC40
进行中（未招募）
1 期
Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple MyelomaHematological MalignanciesNCT03145181Janssen Research & Development, LLC302
进行中（未招募）
1 期
A Study of JNJ-88998377 for Relapsed/Refractory B-cell Non-Hodgkin's LymphomaLymphoma, Non-HodgkinRefractory B-Cell NHLRelapsed B-cell NHLNCT06470438Janssen Research & Development, LLC58
终止
1 期
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory MyelomaRelapsed or Refractory Multiple MyelomaNCT04735575Shanghai EpimAb Biotherapeutics Co., Ltd.40
已完成
1 期
A Study of JNJ-67571244 in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)Leukemia, Myeloid, AcuteMyelodysplastic SyndromesNCT03915379Janssen Research & Development, LLC68