NCT07266441

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for phase_2 multiple-myeloma

Timeline
32mo left

Started Feb 2026

Shorter than P25 for phase_2 multiple-myeloma

Geographic Reach
3 countries

31 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Feb 2026Dec 2028

First Submitted

Initial submission to the registry

November 25, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 5, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 8, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2027

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2028

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

November 25, 2025

Last Update Submit

April 9, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    Up to 2 years and 9 months

Secondary Outcomes (19)

  • Very Good Partial Response (VGPR) or Better Rate

    Up to 2 years and 9 months

  • Complete Response (CR) or Better Rate

    Up to 2 years and 9 months

  • Duration of Response (DoR)

    Up to 2 years and 9 months

  • Progression-Free Survival (PFS)

    Up to 2 years and 9 months

  • Overall Survival (OS)

    Up to 2 years and 9 months

  • +14 more secondary outcomes

Study Arms (1)

JNJ-79635322

EXPERIMENTAL

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

Drug: JNJ-79635322

Interventions

JNJ-79635322DRUG

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

JNJ-79635322

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
  • MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

City of Hope Orange County Lennar Foundation Cancer Center

Irvine, California, 92618, United States

RECRUITING

Cancer and Blood Specialty Clinic

Los Alamitos, California, 90720, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Cancer Specialists of North Florida

Jacksonville, Florida, 32256, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northside Hospital Cancer Institute

Atlanta, Georgia, 30342, United States

RECRUITING

Cancer Care Specialists of Central Illinois

O'Fallon, Illinois, 62269, United States

RECRUITING

University of Iowa

Iowa City, Iowa, 52242, United States

RECRUITING

Mission Cancer Blood

Waukee, Iowa, 50263, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Rutgers Cancer Institute

New Brunswick, New Jersey, 08901, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Cleveland Clinic Foundtation

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology

Austin, Texas, 78705, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Oncology Consultants Texas

Houston, Texas, 77030, United States

RECRUITING

Texas Oncology - Northeast

Tyler, Texas, 75702, United States

RECRUITING

NorthWest Medical Specialties, PLLC

Tacoma, Washington, 98405, United States

RECRUITING

Ha'Emek Medical Center

Afula, 1834111, Israel

RECRUITING

Samson Assuta Ashdod University Hospital

Ashdod, 7747629, Israel

RECRUITING

Hillel Yaffe Medical Center

Hadera, 3820302, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 9112000, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4941492, Israel

RECRUITING

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

National Hospital Organization Shibukawa Medical Center

Gunma, 377-0280, Japan

RECRUITING

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Study Contact

CONTACT

844-434-4210Participate-In-This-Study1@its.jnj.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 5, 2025

Study Start

February 8, 2026

Primary Completion (Estimated)

June 14, 2027

Study Completion (Estimated)

December 12, 2028

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

More information

Locations

IL(6)US(23)JP(2)