A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma

NCT ID: NCT07266441

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 157 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-20
• Study Completion Date: 2028-12-12

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JNJ-79635322

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

Group Type: EXPERIMENTAL

JNJ-79635322

Intervention Type: DRUG

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

Interventions

JNJ-79635322

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Study Contact

Role: CONTACT

Participate-In-This-Study1@its.jnj.com

844-434-4210

Other Identifiers

79635322MMY2001

Identifier Type: OTHER

Identifier Source: secondary_id

2025-521976-80-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

79635322MMY2001

Identifier Type: -

Identifier Source: org_study_id