400 Participants NeededMy employer runs this trial

JNJ-79635322 vs Teclistamab for Multiple Myeloma

(TRIlogy-4 Trial)

Recruiting at 124 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a new treatment, JNJ-79635322, for individuals with multiple myeloma, a type of blood cancer. The study compares this treatment to another drug, teclistamab, to determine which is more effective. Individuals diagnosed with multiple myeloma who have tried at least three other treatments without improvement may be suitable candidates for this trial. Participants will receive injections of either JNJ-79635322 or teclistamab until their disease progresses or they experience side effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants early access to potentially effective treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using any other anticancer treatments before starting the study. It doesn't specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies found JNJ-79635322 safe for patients with relapsed or refractory multiple myeloma, a type of blood cancer. Research shows that most patients tolerate the treatment well, experiencing positive results and manageable side effects.

Teclistamab, another treatment in this study, has a consistent safety record. The FDA has already approved it for multiple myeloma, confirming it meets safety standards for patients. Reports indicate that most patients tolerate it well, with manageable side effects.

Both treatments have demonstrated safety in past research, but individual experiences may vary. Always consult a healthcare provider about options and concerns before joining a trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about JNJ-79635322 for multiple myeloma because it represents a new approach with its bispecific antibody structure. Unlike traditional treatments like proteasome inhibitors and immunomodulatory drugs, JNJ-79635322 targets two different sites, which might enhance its ability to attack cancer cells. This dual-targeting strategy is designed to offer a more precise attack on myeloma cells, potentially leading to better outcomes for patients. Additionally, it’s administered subcutaneously, which can be more convenient and comfortable compared to intravenous options.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

This trial will compare JNJ-79635322 and Teclistamab for treating multiple myeloma. Research has shown that JNJ-79635322 yields promising results, with early studies indicating that 86.1% of patients had a positive response and 96.3% experienced a significant reduction in their cancer. Participants in one arm of this trial will receive JNJ-79635322.

Teclistamab, the treatment being compared in another arm of this trial, has also proven very effective. It has shown a 66% positive response rate in patients whose multiple myeloma returned or didn't respond to previous treatments, indicating it can shrink tumors effectively. Specifically, after 12 months, 78% of patients treated with Teclistamab were still alive, demonstrating its potential to extend life. Both treatments offer significant potential and new hope for patients facing this challenging condition.12467

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma whose cancer has come back or hasn't responded after at least three previous treatments, including specific types of drugs. Participants must have measurable disease and be in generally good physical condition.

Inclusion Criteria

I've had 3 types of treatments for myeloma, including PI, IMiD, and anti-CD38.
I have been diagnosed with multiple myeloma.
My disease can be measured by tests.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either JNJ-79635322 or an Anti BCMAxCD3 bispecific antibody until progressive disease or intolerable toxicity

Up to 5 years and 4 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-79635322
  • Teclistamab

Trial Overview

The study compares two antibody-based treatments: JNJ-79635322 and Teclistamab (a BCMAxCD3 bispecific antibody). Patients are randomly assigned to receive one of these therapies to see which works better against multiple myeloma.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: JNJ-79635322Experimental Treatment1 Intervention
Group II: Anti BCMAxCD3 Bispecific AntibodyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials
1,022
Recruited
6,408,000+
Joaquin Duato profile image

Joaquin Duato

Janssen Research & Development, LLC

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD profile image

Dr. Jijo James, MD

Janssen Research & Development, LLC

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

Updated efficacy and safety results of JNJ-5322, a novel, next ...

The first-in-human study (NCT05652335) in patients with relapsed/refractory multiple myeloma (RRMM) showed an improved or similar safety profile ...

First-in-human study of JNJ-79635322 (JNJ-5322), a novel, ...

Results: As of Jan 15, 2025, 126 pts received JNJ-5322 (36 at 100 mg Q4W); median follow-up (mFU) 8.2 mo. Median age 64 yrs; median 4 prior ...

Early results from Johnson & Johnson's trispecific antibody ...

Among the 36 patients who received the recommended phase 2 dose (RP2D), the overall response rate (ORR) was 86.1 percent. In the 27 patients who ...

NCT05652335 | A Study of JNJ-79635322 in Participants ...

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D[s]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation).

JNJ-5322 Improves Efficacy, Oral Toxicity in Multiple ...

The trispecific antibody JNJ-5322 demonstrated superior efficacy vs approved agents in multiple myeloma in results shared at the EHA 2025 Congress.

Novel Trispecific Antibody Delivers Efficacy and Safety in ...

JNJ-79635322 shows favorable responses and manageable safety in BCMA/GPRC5D-naïve patients with relapsed/refractory multiple myeloma.

JNJ-79635322

The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 ...