A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (TRIlogy-3)

A Phase 2, Open-label Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: JNJ-79635322

• Study Type: Interventional
• Enrollment (Estimated): 157
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • Ha'Emek Medical Center
  • Ashdod, Israel, 7747629
    • Recruiting
    • Samson Assuta Ashdod University Hospital
  • Hadera, Israel, 3820302
    • Recruiting
    • Hillel Yaffe Medical Center
  • Jerusalem, Israel, 9112000
    • Recruiting
    • Hadassah Medical Center
  • Petah Tikva, Israel, 4941492
    • Recruiting
    • Rabin Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Tel Aviv Sourasky Medical Center
• Japan
  • Gunma, Japan, 377-0280
    • Recruiting
    • National Hospital Organization Shibukawa Medical Center
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • O Neal Comprehensive Cancer Center at UAB
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Recruiting
      • Banner MD Anderson Cancer Center
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
    • Irvine, California, United States, 92618
      • Recruiting
      • City of Hope Orange County Lennar Foundation Cancer Center
    • Los Alamitos, California, United States, 90720
      • Recruiting
      • Cancer and Blood Specialty Clinic
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Recruiting
      • Rocky Mountain Cancer Centers
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Cancer Specialists of North Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital Cancer Institute
  • Illinois
    • O'Fallon, Illinois, United States, 62269
      • Recruiting
      • Cancer Care Specialists of Central Illinois
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa
    • Waukee, Iowa, United States, 50263
      • Recruiting
      • Mission Cancer Blood
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Foundtation
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Oncology Associates of Oregon PC Willamette Valley Cancer Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Tennessee Oncology, PLLC
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • SCRI Oncology Partners
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Oncology
    • Houston, Texas, United States, 77030
      • Recruiting
      • MD Anderson Cancer Center
    • Houston, Texas, United States, 77030
      • Recruiting
      • Oncology Consultants Texas
    • Tyler, Texas, United States, 75702
      • Recruiting
      • Texas Oncology - Northeast
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Recruiting
      • Virginia Cancer Specialists
    • Norfolk, Virginia, United States, 23502
      • Recruiting
      • Virginia Oncology Associates
  • Washington
    • Tacoma, Washington, United States, 98405
      • Recruiting
      • Northwest Medical Specialties, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-79635322; Participants will receive JNJ-79635322 as an injection under the skin.	Drug: JNJ-79635322; JNJ-79635322 will be administered as an injection under the skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Response Rate (ORR)	Up to 2 years and 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Time To Next Line of Therapy (TTNT)	Up to 2 years and 9 months
Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity	Up to 2 years and 9 months
Change from Baseline in Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score	From Baseline up to 2 years and 9 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Organization for Research and Treatment of Cancer Quality of life Questionnaire Core 30 (EORTC-QLQ-C30) Scale Score	From Baseline up to 2 years and 9 months
Change from Baseline in Symptoms, Functioning, and HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Version (EQ-5D-5L) Scale Score	From Baseline up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q	Up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Up to 2 years and 9 months
Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L	Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q	Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30	Up to 2 years and 9 months
Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L	Up to 2 years and 9 months
Serum Concentrations for JNJ-79635322	Up to 2 years and 9 months
Number of Participants With Anti JNJ-79635322 Antibodies	Up to 2 years and 9 months
Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)	Up to 2 years and 9 months

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2026
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): December 12, 2028

Study Registration Dates

• First Submitted: November 25, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: 79635322MMY2001 (Other Identifier: Janssen Research & Development, LLC); 2025-521976-80-00 (Registry Identifier: EUCT number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No