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NCT Number: NCT07266441

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking Union Medical College Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • 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

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

Treatment and study plan

JNJ-79635322

Drug

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

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 2 years and 9 months

Secondary outcomes

  1. Very Good Partial Response (VGPR) or Better Rate

    Time frame: Up to 2 years and 9 months

  2. Complete Response (CR) or Better Rate

    Time frame: Up to 2 years and 9 months

  3. Duration of Response (DoR)

    Time frame: Up to 2 years and 9 months

  4. Progression-Free Survival (PFS)

    Time frame: Up to 2 years and 9 months

  5. Overall Survival (OS)

    Time frame: Up to 2 years and 9 months

  6. Time To Next Line of Therapy (TTNT)

    Time frame: Up to 2 years and 9 months

  7. Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity

    Time frame: Up to 2 years and 9 months

  8. 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

    Time frame: From Baseline up to 2 years and 9 months

  9. 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

    Time frame: From Baseline up to 2 years and 9 months

  10. 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

    Time frame: From Baseline up to 2 years and 9 months

  11. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q

    Time frame: Up to 2 years and 9 months

  12. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30

    Time frame: Up to 2 years and 9 months

  13. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L

    Time frame: Up to 2 years and 9 months

  14. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q

    Time frame: Up to 2 years and 9 months

  15. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30

    Time frame: Up to 2 years and 9 months

  16. Percentage of Participants With Meaningful Improvement in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L

    Time frame: Up to 2 years and 9 months

  17. Serum Concentrations for JNJ-79635322

    Time frame: Up to 2 years and 9 months

  18. Number of Participants With Anti JNJ-79635322 Antibodies

    Time frame: Up to 2 years and 9 months

  19. Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)

    Time frame: Up to 2 years and 9 months

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

844-434-4210

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

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

Acronym: TRIlogy-3

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 5, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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