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

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Myeloma

Amyloidosis

Leukemia

Treatment

JNJ-79635322

Clinical Study ID

NCT05652335
CR109234
2023-503679-12-00
2022-001465-12
79635322MMY1001
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

  • Have a documented initial diagnosis of multiple myeloma according to InternationalMyeloma Working Group (IMWG) diagnostic criteria

  • Part 1: Have relapsed or refractory disease, have been treated with a proteasomeinhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy forthe treatment of multiple myeloma (MM),and should have been treated with at least 3prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, andan anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Haverelapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38based 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 chainmultiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) >=10 milligramsper deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) Forparticipants without measurable disease in the serum, urine, or involved FLC,presence of 1 or more focus of extramedullary disease (EMD) which meets thefollowing criteria: extramedullary plasmacytoma not contiguous with a bone lesion,at least 1 lesion >=2 centimeter [cm] (at its greatest dimension) diameter on wholebody Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or wholebody magnetic resonance imaging [MRI] approved by sponsor), and not previouslyradiated (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 withestablished clinical benefit and should have received at least 3 cycles of 1 priorline of therapy or a total of at least 2 cycles of 2 or more prior lines of therapyfor AL amyloidosis

  • Measurable disease at screening defined by at least 1 of the following: seruminvolved free light chain (iFLC) >=50 mg/L or difference between involved anduninvolved 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

Exclusion Criteria:

For participants with relapsed or refractory multiple myeloma:

  • Central Nervous System (CNS) involvement or clinical signs of meningeal involvementof 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), orprimary light chain amyloidosis

  • Received a cumulative dose of corticosteroids equivalent to greater than (>) 140 mgof prednisone within the 14-day period before the start of study treatmentadministration

  • Prior antitumor therapy as follows, in the specified time frame prior to the firstdose of study treatment: (proteasome inhibitor [PI] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modifiedadoptive cell therapy within 90 days [not applicable for Part 2C participants], orCD3-redirecting therapy within 21 days[not applicable for Part 2B or 2Cparticipants])

  • Prior allogeneic transplant within 6 months before the start of study treatmentadministration or autologous transplant within 12 weeks before the start of studytreatment 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 tobaseline levels or to Grade less than or equal to (<=) 1 (except alopecia, tissuepost-RT fibrosis [any grade] or peripheral neuropathy to Grade <=3)

  • The following medical conditions: pulmonary compromise requiring supplemental oxygenuse to maintain adequate oxygenation, human immunodeficiency (HIV) infection, activehepatitis B or C infection, stroke or seizure within 6 months prior to first dose ofstudy 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 IVcongestive heart failure, et cetera)

  • Part 2C: have progressive disease or refractory disease per IMWG after CAR-Tadministration

For participants with previously treated AL amyloidosis:

  • CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. Ifeither 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, strokeor seizure within 6 months prior to first dose of study treatment, significantcardiovascular 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 prednisonewithin 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 therapywithin 21 days)

  • Prior allogeneic transplant within 6 months before the start of study treatmentadministration or autologous transplant within 12 weeks before the start of studytreatment 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 tobaseline levels or to <=1 (except alopecia, tissue post-RT fibrosis [any grade] orperipheral neuropathy to Grade <=3)

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: JNJ-79635322
Phase: 1
Study Start date:
November 22, 2022
Estimated Completion Date:
April 19, 2027

Connect with a study center

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, 9000
    Belgium

    Active - Recruiting

  • CHU de Liege

    Liege, 4000
    Belgium

    Active - Recruiting

  • CHU de Liège

    Liege, 4000
    Belgium

    Active - Recruiting

  • CHU Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • CHU Lyon Sud

    Pierre benite, 69495
    France

    Active - Recruiting

  • Chu Rennes - Hopital Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000
    France

    Completed

  • Institut Claudius Regaud

    Toulouse, 31100
    France

    Active - Recruiting

  • Japanese Red Cross Medical Center

    Shibuya, 150-8935
    Japan

    Active - Recruiting

  • Osaka University Hospital

    Suita-shi, 565-0871
    Japan

    Active - Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550
    Japan

    Active - Recruiting

  • VUMC Amsterdam

    Amsterdam, 1081 HV
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht, 3584 CX
    Netherlands

    Active - Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hosp. Clinico Univ. de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • University College Hospital

    London, W1T 7HA
    United Kingdom

    Active - Recruiting

  • The Christie NHS Foundation Trust - Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    Sutton, SM2 5PT
    United Kingdom

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Active - Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California 92618
    United States

    Active - Recruiting

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mt. Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina 28001
    United States

    Active - Recruiting

  • University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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