700 Participants NeededMy employer runs this trial

JNJ-79635322 vs Teclistamab for Multiple Myeloma

(TRIlogy-5 Trial)

Recruiting at 88 trial locations
SC
Overseen ByStudy Contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Janssen Research & Development, LLC
Must be taking: Anti-CD38 antibody, Lenalidomide
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 aims to compare the effectiveness of a new drug, JNJ-79635322, with an existing treatment, teclistamab, for individuals with multiple myeloma, a type of blood cancer. Participants will receive either JNJ-79635322 or teclistamab as a subcutaneous injection. Suitable candidates for this study include those diagnosed with multiple myeloma, who have undergone 1 to 3 previous treatments, and experience symptoms affecting daily life. The trial seeks to provide improved treatment options for managing multiple myeloma. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

A previous study found JNJ-79635322 to be generally safe, with most side effects being mild and manageable with proper care. Patients experienced responses similar to those seen with CAR T-cell therapy, suggesting potential effectiveness.

Teclistamab also demonstrated a good safety profile. Research indicated it was well tolerated, with manageable side effects such as cytokine release syndrome (a reaction where the body releases too many proteins too quickly) and some risk of infections. However, no major safety concerns emerged.

Both treatments have demonstrated safety when used carefully, with manageable side effects.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-79635322 for multiple myeloma because it represents a novel approach compared to existing treatments like chemotherapy and other monoclonal antibodies. Unlike standard therapies, JNJ-79635322 is a bispecific antibody that targets two different antigens on myeloma cells, potentially leading to more effective tumor cell killing. Additionally, this treatment is administered subcutaneously, which may offer a more convenient and potentially less invasive option compared to traditional intravenous methods. This unique mechanism and delivery method could lead to improved outcomes for patients with multiple myeloma.

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 is promising, with 86.1% of patients who had already received many treatments responding to it. Most patients experienced a positive effect. Meanwhile, Teclistamab has proven effective, with about 65% of patients seeing at least a partial improvement. Additionally, nearly 70% of patients treated with Teclistamab did not experience disease progression after 18 months. Both treatments, tested in separate arms of this trial, have shown significant potential in managing multiple myeloma.25678

Who Is on the Research Team?

JR

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma who have already tried 1 to 3 previous treatments, including a CD38 antibody and lenalidomide. Participants must have measurable disease, be in reasonably good physical condition, and meet certain lab test requirements.

Inclusion Criteria

Clinical laboratory values meeting protocol criteria during screening and within 1 day of start of study treatment
I have been diagnosed with multiple myeloma by my doctor.
I have a tumor that can be measured on scans or tests.
See 2 more

Exclusion Criteria

I do not have myelodysplastic syndrome or any B-cell cancer other than multiple myeloma.
I have or had melanoma that has spread to my brain or spinal fluid.
I have had another cancer that is likely to come back and needs ongoing treatment.
See 3 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 teclistamab as a subcutaneous injection until disease progression or intolerable toxicity

Up to approximately 41 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • JNJ-79635322
  • Teclistamab

Trial Overview

The study compares two drugs—JNJ-79635322 and teclistamab—in people whose multiple myeloma has come back or not responded to earlier treatments. Participants are randomly assigned to receive one of the two medicines.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Arm A: JNJ-79635322Experimental Treatment1 Intervention
Group II: Arm B: TeclistamabActive 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

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 ...

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 ...

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

NCT07258511 | A Study Comparing JNJ-79635322 and an ...

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.

First-in-human JNJ-79635322 trispecific antibody study in ...

J&J 5322 a BCMA and GPRC5D T- cell engaging triccific antibbody demonstrated a manageable safety profile and an overall response rate comparable to carti.

JNJ-79635322 Shows Safety/Favorable Responses in R/ ...

JNJ-79635322 (JNJ-5322), a novel trispecific antibody, demonstrated a manageable safety profile and responses comparable to chimeric antigen receptor (CAR) T- ...

Trispecific Antibody JNJ-79635322 Is Safe and ...

JNJ-79635322 had a tolerable safety profile and elicited responses comparable with those generated by CAR T-cell therapy in relapsed/refractory 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 (dose ...