Recruiting
Phase 2

JNJ-79635322

Sponsor:

Janssen Research & Development, LLC

Code:

NCT07266441

Conditions

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

JNJ-79635322

Study Details

Brief summary:

The purpose of this study is to evaluate how well JNJ-79635322 works (efficacy) in participants with Relapsed or Refractory Multiple Myeloma (RRMM; a cancer that forms in a type of white blood cells called a plasma cell. Cancer is called relapsed if it comes back after treatment and is called 'refractory' if does not respond to treatment) who have received at least 3 prior lines of therapy.

Conditions

Multiple Myeloma

Study ID

NCT07266441

Start date

Feb 8, 2026

Status verified date

Aug, 2026

Completion date

Dec 12, 2028

Anticipated

Primary completion date

Jun 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:

1. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
2. Measurable disease at screening as assessed by central laboratory
  • Received at least 3 prior lines of antimyeloma therapy including a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-cluster of differentiation (CD) 38 monoclonal antibody (mAb)
  • Documented evidence of progressive disease(PD) or failure to achieve a response to the last line of therapy based on investigator's determination of response by the IMWG criteria
  • Have discontinued concurrent use of any other anticancer treatment (including nonpalliative radiotherapy) or investigational agent
  • Have an eastern cooperative oncology group (ECOG) performance status (PS) of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

  • Suspected or known allergies, hypersensitivity, or intolerance to excipients of JNJ-79635322
  • Had major surgery within 2 weeks before first dose or has planned major surgery during study treatment phase
  • Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
  • Participant has leptomeningeal disease
  • Participant has a prior or concurrent second malignancy the natural history or treatment of which could likely interfere with any study endpoints of safety or the efficacy of the study treatment

Study Design

Enrollment

157 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: JNJ-79635322

Participants will receive JNJ-79635322 as an injection under the skin.

Interventions

JNJ-79635322

JNJ-79635322 will be administered as an injection under the skin.

Primary outcome measure

  • Overall Response Rate (ORR) [ Time Frame: Up to 2 years and 9 months ]

Central Contacts and Locations

Locations

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Northside Hospital Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30342

Cancer Care Specialists of Central Illinois

Recruiting

O'Fallon, Illinois, United States, 62269

Mission Cancer Blood

Recruiting

Waukee, Iowa, United States, 50263

Oncology Associates of Oregon PC Willamette Valley Cancer Institute

Recruiting

Eugene, Oregon, United States, 97401

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.