Not recruiting

A Phase 2 Study of JNJ-79635322 in Patients with Relapsed or Refractory Multiple Myeloma

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is being done in Relapsed or Refractory Multiple Myeloma, a type of cancer that starts in plasma cells, which are a kind of blood cell found in the bone marrow. In this disease, the cancer has either come back after treatment or has not improved with treatment. The study uses JNJ-79635322, a medicine given as an injection under the skin. It is a special type of antibody, which is a protein designed to attach to certain targets on cells and help the immune system attack the cancer.

The purpose of the study is to see how well JNJ-79635322 works in people with this form of multiple myeloma. The study is open-label, which means everyone in the study receives the same treatment and knows what it is. Participants will receive the study medicine and be followed over time while the study team checks how the disease responds and watches for side effects.

This study is for people who have already had several previous treatments, including a PI, an IMiD, and an anti-CD38 antibody. A PI is a medicine that blocks a protein used by cancer cells to grow, an IMiD is a medicine that helps the immune system fight cancer, and an anti-CD38 antibody is a medicine that targets a protein on myeloma cells.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study treatment begins
After joining the study, you receive JNJ-79635322, which is given by subcutaneous use meaning it is injected under the skin.
The source data identifies JNJ-79635322 as a solution for injection.
The source data does not provide a dose amount, dosing frequency, or treatment duration.
Step 2
Treatment period
You continue in the study while JNJ-79635322 is administered as directed by the trial plan.
The study is designed to evaluate how well JNJ-79635322 works in relapsed or refractory multiple myeloma (RRMM), which means a type of blood cancer that has returned or has not responded to treatment.
The main result measured in the study is the overall response rate, which means the number of participants whose cancer shows a response to treatment.
Step 3
Study completion
Your participation continues until the study period ends.
The estimated study period runs from 2026-03-15 to 2029-05-31.
The source data does not describe any other trial stages, medication changes, or additional procedures.

Who can join the trial?

7 criteria

Have a confirmed diagnosis of multiple myeloma based on the study’s required medical criteria.
Have measurable disease at screening, meaning the cancer can be measured in the blood or urine by one of these tests: serum M-protein of at least 0.5 g/dL, or serum Ig FLC of at least 10 mg/dL with an abnormal serum kappa/lambda free light chain ratio, or urine M-protein of at least 200 mg in 24 hours.
Have already received at least 3 previous lines of treatment for myeloma, including all of the following: a PI (a proteasome inhibitor, a drug that blocks a protein system cancer cells use to survive), an IMiD (an immunomodulatory drug, a medicine that changes how the immune system works), and an anti-CD38 monoclonal antibody (a targeted antibody treatment).
Have clear evidence that the disease has gotten worse after treatment, or that the last treatment did not produce at least a partial response (meaning the cancer did not shrink enough to count as a response).
Have stopped any other cancer treatment before joining the study, including non-palliative radiotherapy (radiation used to treat cancer, not just to relieve symptoms), and stopped any investigational agent (a treatment still being studied).
Have side effects from earlier cancer treatment that have improved to Grade 1 or better, meaning mild or gone, except for hair loss, skin thickening or color change, dry mouth, hormone problems controlled with replacement medicine, peripheral neuropathy (nerve damage that can cause numbness or tingling), and dysgeusia (changed taste), which must be Grade 2 or better, meaning mild to moderate.
Have an ECOG performance status of 0 to 2 at screening and right before treatment starts. This is a measure of how well a person can do daily activities, where 0 means fully active and 2 means able to care for yourself but unable to do heavy work.

Who cannot join the trial?

5 criteria

Has a known or suspected allergy, hypersensitivity (an overreaction of the immune system), or intolerance to any ingredient in JNJ-79635322.
Had major surgery within 2 weeks before the first dose of the study treatment, or has planned major surgery during the treatment period. Surgery done with local anesthesia may still be allowed.
Has had another cancer in the past or currently has another cancer, if that cancer or its treatment could likely affect the study results or the safety of the study treatment.
Has known or suspected central nervous system involvement, meaning the disease has affected the brain or spinal cord, or has clinical signs of meningeal involvement, meaning signs that the coverings around the brain or spinal cord may be involved. If this is suspected, a negative whole brain MRI and lumbar cytology are required; if not negative, the person cannot participate.
Has leptomeningeal disease, meaning cancer cells are present in the thin layers covering the brain and spinal cord.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Azienda Ospedaliero Universitaria Di Sassari
Responsive
Sassari, Italy
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

JNJ-79635322 is the study drug being tested in this trial. It is a lab-made antibody given under the skin as an injection. It is designed to help the immune system find and attack multiple myeloma cells by linking T cells, a type of immune cell, to targets found on the cancer cells. The goal of the trial is to see how well this medicine works in people whose multiple myeloma has come back or has not responded to earlier treatments.

IGG1 TRISPECIFIC MONOCLONAL ANTIBODY AGAINST T-CELL RECEPTOR CD3, B-CELL MATURATION ANTIGEN AND G PROTEIN-COUPLED RECEPTOR CLASS C GROUP 5 MEMBER D

What is already known about the treatment

JNJ-79635322 - JNJ-79635322 is given as a solution for injection under the skin, which means it is administered by subcutaneous use. It is an experimental medicine and is still being studied in clinical trials, so it is not yet an established treatment in routine medical practice. It is being developed for relapsed or refractory multiple myeloma, a type of blood cancer that has come back or did not respond to earlier treatment, and it belongs to the group of trispecific monoclonal antibodies. At the molecular level, it is designed to bind to CD3 on T cells, BCMA on myeloma cells, and GPRC5D on cancer cells, helping the immune system recognize and attack the cancer cells.

Investigated diseases

Relapsed or Refractory Multiple Myeloma - A cancer of plasma cells, which are white blood cells found in the bone marrow and help make antibodies. It begins when these abnormal cells grow out of control and crowd out normal blood-forming cells. As the disease progresses, the abnormal cells can collect in the bones and bone marrow and spread more widely within the body. In relapsed or refractory disease, the cancer has returned after treatment or has stopped responding to prior treatment.