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NCT05652335From ClinicalTrials.govRecruiting

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

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

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Janssen Research & Development, LLC
Enrolment target
180
Started
22 November 2022
Main results due
19 April 2027
Study sites
29
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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)

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(29)

  • City of Hope

    Duarte, California, United States

    Recruiting

  • City of Hope Orange County Lennar Foundation Cancer Center

    Irvine, California, United States

    Recruiting

  • University of California San Francisco

    San Francisco, California, United States

    Recruiting

  • Colorado Blood Cancer Institute

    Denver, Colorado, United States

    Recruiting

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, United States

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, United States

    Recruiting

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

    Philadelphia, Pennsylvania, United States

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • UZ Antwerpen

    Edegem, Belgium

    Recruiting

  • UZ Gent

    Ghent, Belgium

    Recruiting

  • CHU de Liege

    Liège, Belgium

    Recruiting

  • CHU Nantes

    Nantes, France

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, France

    Recruiting

  • Chu Rennes Hopital Pontchaillou

    Rennes, France

    Completed

  • Institut Claudius Regaud

    Toulouse, France

    Recruiting

  • Japanese Red Cross Medical Center

    Shibuya City, Japan

    Recruiting

  • Osaka University Hospital

    Suita-shi, Japan

    Recruiting

  • The Cancer Institute Hospital of JFCR

    Tokyo, Japan

    Completed

  • VUMC Amsterdam

    Amsterdam, Netherlands

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, Netherlands

    Recruiting

  • UMC Utrecht

    Utrecht, Netherlands

    Recruiting

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, Spain

    Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, Spain

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, Spain

    Recruiting

  • Clinica Univ. de Navarra

    Pamplona, Spain

    Recruiting

  • Hosp Clinico Univ de Salamanca

    Salamanca, Spain

    Recruiting

  • University College Hospital

    London, United Kingdom

    Recruiting

  • Royal Marsden Hospital

    Sutton, United Kingdom

    Recruiting

Showing 29 of 29 sites. 27 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05652335. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amy | Trialion