ISRCTN13185938进行中（未招募）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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 02/01/2024:
- •For participants with relapsed or refractory multiple myeloma:
- •1. Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- •2. 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
- •3. Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- •4. Have measurable disease at screening as defined by at least 1 of the following:
- •4.1. Serum M-protein level =0.5 g/dL; or
- •4.2. Urine M-protein level =200 mg/24 h; or
- •4.3. Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) =10 mg/dL and abnormal serum Ig kappa lambda FLC ratio
- •4.4. 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 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
- •For participants with previously treated AL amyloidosis:
- •5. Initial histopathological diagnosis of amyloidosis
- •6. 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
- •7. 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
- •8. One or more organs impacted by systemic AL amyloidosis
- •9. Left ventricular ejection fraction (LVEF) =45%
- •Previous inclusion criteria:
- •1. Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- •2. Have relapsed or refractory disease and have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM)
- •3. Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
- •4. Have measurable disease at screening as defined by at least 1 of the following:
- •4.1. Serum M-protein level greater than or equal to (>=) 0.5 grams per deciliter (g/dL); or
- •4.2. Urine M-protein level >=200 milligrams (mg)/24 hours; or
- •4.3. 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
- •4.4. For pa
排除标准
- •Current exclusion criteria as of 02/01/2024:
- •For participants with relapsed or refractory multiple myeloma:
- •1. 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.
- •2. Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- •3. Received a cumulative dose of corticosteroids equivalent to >140 mg of prednisone within the 14-day period before the start of study treatment administration
- •4. Prior antitumor therapy within 21 days 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 or CD-3 redirecting therapy within 90 days)
- •5. Prior allogeneic transplant within 6 months or autologous transplant within 12 weeks
- •6. Live, attenuated vaccine within 4 weeks before the first dose of study treatment
- •7. Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade =1 (except alopecia, tissue post-RT fibrosis [any grade] or peripheral neuropathy to Grade =3)
- •8. 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 the 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, etc)
- •For participants with previously treated AL amyloidosis:
- •9. CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required.
- •10. Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis
- •11. Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
- •12. Pulmonary compromise requiring supplemental oxygen use
- •13. 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
- •14. Previous or current diagnosis of symptomatic multiple myeloma
- •15. Macroglossia that impairs swallowing difficulty
- •16. Received a cumulative dose of corticosteroids equivalent to >140 mg of prednisone within the 14-day period before the start of study treatment administration
- •17. 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)
- •18. Prior allogeneic transpla
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