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JNJ-79635322 versus a BCMA×CD3 bispecific antibody for relapsed or refractory multiple myeloma

A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti CD38 Antibody

Phase 3 Interventional Janssen Research & Development, LLC · NCT07258511

This trial tests whether JNJ-79635322 works better than a BCMA×CD3 bispecific antibody in people with relapsed or refractory multiple myeloma who have had at least three prior therapies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Drugs / interventionsTeclistamab
Locations43 sites (Los Angeles, California and 42 other locations)
Trial IDNCT07258511 on ClinicalTrials.gov

What this trial studies

This is a phase 3 interventional trial comparing the experimental agent JNJ-79635322 with an anti-BCMA×CD3 bispecific antibody (teclistamab) in adults with relapsed or refractory multiple myeloma. Eligible participants have measurable disease and have received at least three prior lines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38 antibody, and must have stopped other anticancer treatments before enrollment. Participants meeting screening criteria (including ECOG performance status 0–2) will be assigned to receive one of the study agents and followed for responses and safety per protocol, with disease measurements confirmed by a central laboratory. The study is sponsored by Janssen and is being conducted at multiple U.S. cancer centers.

Who should consider this trial

Good fit: Ideal candidates are adults with relapsed or refractory multiple myeloma who have measurable disease, an ECOG performance status of 0–2, and who have received at least three prior lines of therapy including a PI, an IMiD, and an anti-CD38 antibody.

Not a fit: Patients who are newly diagnosed, have received fewer than three prior lines of therapy, have poor performance status, or have ongoing uncontrolled infections or other major exclusion conditions are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this could provide another effective treatment option that may prolong disease control for heavily pretreated multiple myeloma patients.

How similar studies have performed: Other BCMA-targeted therapies, including BCMA×CD3 bispecific antibodies like teclistamab and BCMA-directed CAR-Ts, have shown clinical activity in heavily pretreated myeloma, while JNJ-79635322 represents a newer investigational agent being compared against that established approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 antibody
* Documented evidence of progressive disease (PD) or failure to achieve a response (that is partial response \[PR\] or better) to the last line of therapy based on investigator's determination of response by 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 of 0 to 2 at screening and immediately before the start of study treatment administration

Exclusion:

* Active hepatitis of infectious origin
* Known active or prior central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM
* Suspected or known allergies, hypersensitivity, or intolerance to the excipients of JNJ-79635322 and Teclistamab
* Major surgery , (example, requiring general anesthesia) within 2 weeks before first dose, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
* Received or plans to receive any live, attenuated vaccine within 4 weeks before the first dose of study treatment, during, or within 90 days after the last dose of study treatment

Where this trial is running

Los Angeles, California and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple Myeloma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.