RecruitingPhase 1NCT05652335

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


Sponsor

Janssen Research & Development, LLC

Enrollment

180 participants

Start Date

Nov 22, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria11

  • 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 Criteria23

  • 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)

Interventions

DRUGJNJ-79635322

JNJ-79635322 will be administered as SC injection.


Locations(29)

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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NCT05652335


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