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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 (TRIlogy-3)

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

Takizawa Manami

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Medical Information Center

Janssen Pharmaceutical K.K.

5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo

+81-120-183-275

DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com

Pending

June. 11, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- Documented diagnosis of multiple myeloma (MM) as defined by the criteria below:
a. MM diagnosis according to the international myeloma working group (IMWG) diagnostic criteria
b. 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 anticluster 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

- 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

Both

Multiple Myeloma

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.

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

2. Very Good Partial Response (VGPR) or Better Rate
[Time Frame: Up to 2 years and 9 months]

3. Complete Response (CR) or Better Rate
[Time Frame: Up to 2 years and 9 months]

4. Duration of Response (DoR)
[Time Frame: Up to 2 years and 9 months]

5. Progression-Free Survival (PFS)
[Time Frame: Up to 2 years and 9 months]

6. Overall Survival (OS)
[Time Frame: Up to 2 years and 9 months]

7. Time To Next Line of Therapy (TTNT)
[Time Frame: Up to 2 years and 9 months]

8. Number of Participants With Treatment-Emergent Adverse Event (TEAE) by Severity
[Time Frame: Up to 2 years and 9 months]

9. 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]

10. 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]

11. 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]

12. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by MySIm-Q
[Time Frame: Up to 2 years and 9 months]

13. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EORTC-QLQ-C30
[Time Frame: Up to 2 years and 9 months]

14. Time to Worsening in Symptoms, Functioning, and HRQoL as Assessed by EQ-5D-5L
[Time Frame: Up to 2 years and 9 months]

15. 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]

16. 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]

17. 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]

18. Serum Concentrations for JNJ-79635322
[Time Frame: Up to 2 years and 9 months]

19. Number of Participants With Anti JNJ-79635322 Antibodies
[Time Frame: Up to 2 years and 9 months]

20. Number of Participants With JNJ-79635322 Neutralizing Antibodies (NAb)
[Time Frame: Up to 2 years and 9 months]

+81-279-23-1010

Sept. 24, 2025

Yes

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.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

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