[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"previously-treated-amyloid-light-chain-al-amyloidosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:previously-treated-amyloid-light-chain-al-amyloidosis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100489378","phase-1-a-study-of-jnj-79635322-in-participants-with-relapsed-or-refractory-multiple-myeloma-or-previously-treated-amyloid-light-chain-al-amyloidosis-100489378",false,"NCT05652335","A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis","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","Inclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n* 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\n* Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* 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\u002FdL); or b) Urine M-protein level \\>=200 milligrams (mg)\u002F24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \\>=10 milligrams per deciliter (mg\u002FdL) 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)\n\nFor participants with previously treated AL amyloidosis:\n\n* Initial histopathological diagnosis of amyloidosis\n* 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\n* Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \\>=50 mg\u002FL or difference between involved and uninvolved free light chains (dFLC) \\>=50 mg\u002FL, or serum m-protein \\>= 0.5 g\u002FdL\n* One or more organs impacted by systemic AL amyloidosis\n* Left ventricular ejection fraction (LVEF) \\>=45%\n\nExclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* 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\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis\n* 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\n* 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\\])\n* 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\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\\\u003C=) 1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\\u003C=3)\n* 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 \\\u003C=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)\n* Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration\n\nFor participants with previously treated AL amyloidosis:\n\n* CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required\n* Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome\n* Pulmonary compromise requiring supplemental oxygen use\n* 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\n* Previous or current diagnosis of symptomatic multiple myeloma\n* Macroglossia that impairs swallowing difficulty\n* Received a cumulative dose of corticosteroids equivalent to \\> 140 mg of prednisone within the 14-day period before the start of study treatment administration\n* 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)\n* 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\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to \\\u003C=1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\\u003C=3)","ALL","18 Years",{"count":19,"type":20},180,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","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).",[26,27],"Relapsed or Refractory Multiple Myeloma","Previously Treated Amyloid Light-chain (AL) Amyloidosis","RECRUITING","2026-06-04",{"date":31,"type":32},"2026-06-05","ACTUAL",{"date":34,"type":32},"2022-11-22",{"date":36,"type":20},"2028-08-28",{"name":38,"class":39},"Janssen Research & Development, LLC","INDUSTRY",29]