a study of jnj-79635322 in participants with relapsed or refractory multiple myeloma or previously treated amyloid light-chain (al) amyloidosis

Conditions: Relapsed or Refractory Multiple Myeloma; Previously Treated Amyloid Light-chain (AL) Amyloidosis

Summary: 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).


Eligibility criteria:
inclusion criteria: 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% exclusion criteria: 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)