NCT05652335RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 22 Nov 2022
- Primary completion date
- 19 Apr 2027
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Amyloidosis, Multiple myeloma
- NCT number
- NCT05652335
- EU CT number
- 2023-503679-12-00
- EudraCT number
- 2022-001465-12
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 180
- From 22 Nov 2022 to the primary completion date, 19 Apr 2027
- 29 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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
- 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)
Other illness
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis
- Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome
Other
- 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
- 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
- Pulmonary compromise requiring supplemental oxygen use
- Macroglossia that impairs swallowing difficulty
Who the study is looking for
- 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%
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital Coordinator of this site? Confirm its status | Edegem | Belgium | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| CHU de Liège Coordinator of this site? Confirm its status | Liège | Belgium | Recruiting |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Lyon-Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Recruiting |
| Institut Universitaire du Cancer Toulouse - Oncopole Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| University College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal Marsden Hospital Coordinator of this site? Confirm its status | Sutton | United Kingdom | Recruiting |
| Japanese Red Cross Medical Center Coordinator of this site? Confirm its status | Shibuya City | Japan | Active, not recruiting |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Active, not recruiting |
| The Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Tokyo | Japan | Completed |
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| METC Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| City of Hope Orange County Lennar Foundation Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Icahn School of Medicine at Mt. Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.