JNJ-79635322 for Multiple Myeloma and AL Amyloidosis

Recruiting at 39 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Janssen Research & Development, LLC

Must be taking: Proteasome inhibitors, IMiD agents, Anti-CD38

Must not be taking: Corticosteroids, Gene-modified therapy

Disqualifiers: CNS involvement, Plasma cell leukemia, others

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

Compensation: Varies

Number of Visits: Unknown

180 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 individuals with multiple myeloma or AL amyloidosis. The goal is to determine a safe dose and assess patient tolerance. In the first part, researchers will gradually increase the dose to identify the optimal amount for further testing. The second part will focus on evaluating the treatment's effectiveness at that dose. Individuals who have tried other treatments and still experience symptoms might be suitable candidates for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before starting the study treatment. Specifically, you must not have taken proteasome inhibitors or radiotherapy within 14 days, immunomodulatory drugs within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days before the first dose of the study treatment.

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

Research is testing JNJ-79635322 for safety in treating multiple myeloma and AL amyloidosis. Early studies suggest it might benefit patients who have undergone many treatments for multiple myeloma. However, this is the first human trial, so researchers are still learning about its tolerability and potential side effects.

As this trial is in the early stages, the main goal is to determine a safe dose for future studies. Detailed safety information is limited, but early trials like this are closely monitored for possible side effects. Researchers carefully observe participants to ensure their safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about JNJ-79635322 because it represents a novel approach to treating multiple myeloma and AL amyloidosis. Unlike traditional treatments that often target the cancer cells directly, JNJ-79635322 works differently by targeting specific proteins involved in the disease process. This unique mechanism could potentially offer a more precise treatment option, reducing the impact on healthy cells and potentially leading to fewer side effects. Moreover, the potential for JNJ-79635322 to be effective at lower doses, as determined in the dose escalation phase, may offer a new level of flexibility and safety in treatment regimens.

What evidence suggests that JNJ-79635322 might be an effective treatment for multiple myeloma and AL amyloidosis?

Research has shown promising results for JNJ-79635322, which participants in this trial will receive, in treating multiple myeloma. Early findings revealed that 86.1% of patients, who had already tried many treatments, responded positively to this new treatment, indicating significant improvement. JNJ-79635322 is a trispecific antibody, a type of drug that can attack cancer cells in different ways. These early results suggest it might work well for people with multiple myeloma who haven't had success with other treatments. ^{1 3 4 6}

Who Is on the Research Team?

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 relapsed or refractory multiple myeloma or AL amyloidosis who've had several prior treatments, including a proteasome inhibitor, IMiD agent, and anti-CD38 therapy. They must have measurable disease indicators like specific protein levels in blood/urine or certain types of lesions. Participants need to be fairly active and healthy otherwise (ECOG status 0 or 1) and not suitable for other proven therapies.

Inclusion Criteria

My condition allows me to carry out all my usual activities without extra help.

I was diagnosed with AL amyloidosis based on tissue analysis.

My heart pumps well, with an ejection fraction of 45% or higher.

Exclusion Criteria

I've taken more than 140 mg of steroids in the last 2 weeks for AL amyloidosis.

My side effects from previous cancer treatments, except for hair loss, scarring from radiation, or nerve damage up to a moderate level, have mostly gone away.

I need extra oxygen due to lung issues from my AL amyloidosis treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants will receive JNJ-79635322 with dose escalation to identify the recommended phase 2 dose (RP2D)

Up to 2 years 5 months

Dose Expansion

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1

Up to 2 years 5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• JNJ-79635322

Trial Overview The study tests JNJ-79635322's safety at different doses in people with multiple myeloma or AL amyloidosis who haven't responded well to standard treatments. It has two parts: finding the safest dose (Part 1) and then seeing how well it works at that dose across different patient groups (Part 2).

How Is the Trial Designed?

Group I: Part 2: Dose Expansion Experimental Treatment 1 Intervention

Participants will receive JNJ-79635322 at the RP2D regimen(s) determined in Part 1.

Group II: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Participants will receive JNJ-79635322. The dose will be escalated sequentially until the recommended phase 2 dose (RP2D) regimen(s) have been identified.

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. pharmexec.com pharmexec.com/view/johnson-johnson-first-class-trispecific-antibody-high-response-rates-relapsed-refractory-multiple-myeloma

Johnson & Johnson's First-in-Class Trispecific Antibody ... Early Phase I results for JNJ-79635322 demonstrated an 86.1% overall response rate in heavily pretreated multiple myeloma patients.

2. 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 ...

3. isrctn.com isrctn.com/ISRCTN13185938

A study of JNJ-79635322 in participants with relapsed or ... The study aims to assess the safety of JNJ-79635322 (study drug) given to participants with relapsed or refractory MM or previously treated AL amyloidosis.

4. library.ehaweb.org library.ehaweb.org/eha/2025/eha2025-congress/4159177/rakesh.popat.first-in-human.study.of.jnj-79635322.28jnj-532229.a.novel.html

FIRST-IN-HUMAN STUDY OF JNJ-79635322 (JNJ-5322) ... Bispecific antibodies (BsAbs) have begun to transform outcomes in relapsed/refractory multiple myeloma (RRMM). Emerging data suggest that ...

5. myeloma.org myeloma.org/sparkcures/trial/1883/NCT05652335/locations

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 ...

6. 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 ... Phase 1 trial demonstrates encouraging clinical activity of investigational immunotherapy for relapsed or refractory multiple myeloma.