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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
  • - 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.
  • - 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.
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) >=50mg/L or difference between involved and uninvolved free light chains (dFLC) >=50mg/L, or serum m-protein >= 0.5g/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 within 21 days 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, 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 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) 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05652335
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Research & Development, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Research & Development, LLC Clinical Trial
Principal Investigator Affiliation Janssen Research & Development, LLC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Belgium, France, Netherlands, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Relapsed or Refractory Multiple Myeloma, Previously Treated Amyloid Light-chain (AL) Amyloidosis
Arms & Interventions

Arms

Experimental: Part 1: Dose Escalation

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

Experimental: Part 2: Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Interventions

Drug: - JNJ-79635322

JNJ-79635322 will be administered as SC injection.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope, Duarte, California

Status

Recruiting

Address

City of Hope

Duarte, California, 91010

Irvine, California

Status

Recruiting

Address

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618

Icahn School of Medicine at Mt. Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

International Sites

UZ Antwerpen, Edegem, Belgium

Status

Recruiting

Address

UZ Antwerpen

Edegem, , 2650

UZ Gent, Gent, Belgium

Status

Recruiting

Address

UZ Gent

Gent, , 9000

CHU de Liege, Liege, Belgium

Status

Recruiting

Address

CHU de Liege

Liege, , 4000

CHU Nantes, Nantes, France

Status

Recruiting

Address

CHU Nantes

Nantes, , 44093

CHU Lyon Sud, Pierre benite, France

Status

Recruiting

Address

CHU Lyon Sud

Pierre benite, , 69495

Chu Rennes Hopital Pontchaillou, Rennes, France

Status

Recruiting

Address

Chu Rennes Hopital Pontchaillou

Rennes, , 35000

Institut Claudius Regaud, Toulouse, France

Status

Recruiting

Address

Institut Claudius Regaud

Toulouse, , 31100

VUMC Amsterdam, Amsterdam, Netherlands

Status

Recruiting

Address

VUMC Amsterdam

Amsterdam, , 1081 HV

UMC Utrecht, Utrecht, Netherlands

Status

Recruiting

Address

UMC Utrecht

Utrecht, , 3584 CX

Hosp. Univ. Germans Trias I Pujol, Badalona, Spain

Status

Recruiting

Address

Hosp. Univ. Germans Trias I Pujol

Badalona, , 08916

Hosp. Clinic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hosp. Clinic de Barcelona

Barcelona, , 08036

Hosp. Univ. Fund. Jimenez Diaz, Madrid, Spain

Status

Recruiting

Address

Hosp. Univ. Fund. Jimenez Diaz

Madrid, , 28040

Clinica Univ. de Navarra, Pamplona, Spain

Status

Recruiting

Address

Clinica Univ. de Navarra

Pamplona, , 31008

Hosp. Clinico Univ. de Salamanca, Salamanca, Spain

Status

Recruiting

Address

Hosp. Clinico Univ. de Salamanca

Salamanca, , 37007

University College Hospital, London, United Kingdom

Status

Recruiting

Address

University College Hospital

London, , W1T 7HA

Royal Marsden Hospital, Sutton, United Kingdom

Status

Recruiting

Address

Royal Marsden Hospital

Sutton, , SM2 5PT