JNJ-79635322 for Multiple Myeloma

(TRIlogy-3 Trial)

Recruiting at 36 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: Proteasome inhibitors, Immunomodulatory drugs, Anti-CD38 mAbs

Disqualifiers: CNS involvement, Leptomeningeal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

157 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called JNJ-79635322 for people with multiple myeloma, a type of blood cancer. It targets those whose cancer has returned or not responded to at least three different therapies. Participants will receive the treatment through a subcutaneous injection. Suitable candidates are those with multiple myeloma who have tried several treatments and still have active or recurring disease. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

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

Is there any evidence suggesting that JNJ-79635322 is likely to be safe for humans?

A previous study demonstrated that JNJ-79635322 had a safety profile either better or similar to other treatments for patients with relapsed or refractory multiple myeloma. The side effects were less severe or comparable to those from other treatments. Research also indicates that the treatment's side effects were generally mild and manageable. Overall, initial findings suggest that JNJ-79635322 is safe for patients similar to those who might join the current trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Unlike the standard treatments for multiple myeloma, which often include oral medications, chemotherapy, or IV infusions, JNJ-79635322 is administered as a simple injection under the skin. This makes it potentially more convenient and less invasive for patients. Researchers are excited about JNJ-79635322 because it offers a novel approach to treatment that could improve patient comfort and adherence. Additionally, its unique delivery method might reduce some of the side effects associated with more traditional forms of administration.

What evidence suggests that JNJ-79635322 might be an effective treatment for Multiple Myeloma?

Research has shown that JNJ-79635322 yields promising results for patients with relapsed or refractory multiple myeloma, a type of blood cancer. In one study, 86.1% of patients who received the recommended dose responded well to the treatment. Additionally, 96.3% of patients experienced a very good partial response, indicating significant improvement in their cancer. This treatment, which participants in this trial will receive, is a specialized antibody designed to target cancer cells more precisely. Early findings suggest it is generally safe, offering hope for those who have tried other treatments. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with multiple myeloma that has come back or not responded after at least 3 previous treatments, including specific types of drugs. Participants must have measurable disease and be in generally good physical condition. People with certain allergies, recent major surgery, or brain involvement from cancer cannot join.

Inclusion Criteria

I have been diagnosed with multiple myeloma.

My disease can be measured by tests.

I've had 3 types of treatments for myeloma, including PI, IMiD, and anti-CD38.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive JNJ-79635322 as an injection under the skin

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-79635322

Trial Overview

The study is testing a new drug called JNJ-79635322 to see how well it works in people whose multiple myeloma has returned or stopped responding to standard treatments. All participants will receive this experimental treatment.

How Is the Trial Designed?

Group I: JNJ-79635322 Experimental Treatment 1 Intervention

Participants will receive JNJ-79635322 as an injection under the skin.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

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

Janssen Research & Development, LLC

Chief Medical Officer since 2014

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

Citations

1.

ashpublications.org

ashpublications.org/blood/article/146/Supplement%201/4042/551994/Updated-efficacy-and-safety-results-of-JNJ-5322-a

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 ...

2.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.7505

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 ...

3.

jnj.com

jnj.com/media-center/press-releases/early-results-from-johnson-johnsons-trispecific-antibody-show-promising-response-in-heavily-pretreated-multiple-myeloma-patients

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05652335

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).

5.

cancernetwork.com

cancernetwork.com/view/jnj-5322-improves-efficacy-oral-toxicity-in-multiple-myeloma

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.

6.

targetedonc.com

targetedonc.com/view/novel-trispecific-antibody-delivers-efficacy-and-safety-in-myeloma

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.

7.

myeloma.org

myeloma.org/sparkcures/trial/1883/NCT05652335

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 ...