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RECRUITING Phase 1 ClinicalTrials.gov

A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT05652335

Registry updated: 2026-09-28
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Description

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).

Interventions

  • JNJ-79635322 (Drug)
    JNJ-79635322 will be administered as SC injection.

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)

Conditions

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

Locations

  • City of Hope — Duarte, California, United States
  • City of Hope Orange County Lennar Foundation Cancer Center — Irvine, California, United States
  • University of California San Francisco — San Francisco, California, United States
  • Colorado Blood Cancer Institute — Denver, Colorado, United States
  • Icahn School of Medicine at Mt. Sinai — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Levine Cancer Institute — Charlotte, North Carolina, United States
  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States
  • MD Anderson Cancer Center — Houston, Texas, United States
  • UZ Antwerpen — Edegem, Belgium
  • UZ Gent — Ghent, Belgium
  • CHU de Liege — Liège, Belgium
  • CHU Nantes — Nantes, France
  • CHU Lyon Sud — Pierre-Bénite, France
  • Chu Rennes Hopital Pontchaillou — Rennes, France
  • Institut Claudius Regaud — Toulouse, France
  • Japanese Red Cross Medical Center — Shibuya City, Japan
  • Osaka University Hospital — Suita-shi, Japan
  • The Cancer Institute Hospital of JFCR — Tokyo, Japan
  • VUMC Amsterdam — Amsterdam, Netherlands
  • Universitair Medisch Centrum Groningen — Groningen, Netherlands
  • UMC Utrecht — Utrecht, Netherlands
  • Hosp. Univ. Germans Trias I Pujol — Badalona, Spain
  • Hosp Clinic de Barcelona — Barcelona, Spain
  • Hosp Univ Fund Jimenez Diaz — Madrid, Spain
  • Clinica Univ. de Navarra — Pamplona, Spain
  • Hosp Clinico Univ de Salamanca — Salamanca, Spain
  • University College Hospital — London, United Kingdom
  • Royal Marsden Hospital — Sutton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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