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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With 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

A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma (NCT07258511) is a Phase 3 interventional studying Multiple Myeloma, sponsored by Janssen Research & Development, LLC. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Multiple Myeloma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 400 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

JNJ-79635322

JNJ-79635322 will be administered as SC injection.

DRUG

Teclistamab

Teclistamab will be administered as SC injection.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Yale Cancer Center
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
Emory University
Atlanta, Georgia, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Mount Sinai Chelsea
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Durham VAMC
Durham, North Carolina, United States
Oregon Health And Science University
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Box Hill Hospital
Box Hill, Australia
Mater Misericordiae Ltd
Brisbane, Australia
St Vincents Hospital Melbourne
Fitzroy, Australia
The Alfred Hospital
Melbourne, Australia
Gold Coast University Hospital
Southport, Australia
Hospital De Clinicas De Porto Alegre
Porto Alegre, Brazil
Soroka Medical Center
Beersheba, Israel
Bnai Zion Medical Center
Haifa, Israel

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07258511), the sponsor (Janssen Research & Development, LLC), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07258511 clinical trial studying?

The purpose of this study is to evaluate how well JNJ-79635322 works when compared with an anti-B-cell maturation antigen (BCMA)xCD3 bispecific antibody. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07258511?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07258511?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07258511. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07258511. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.