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Phase 3 Study Comparing JNJ-79635322 with Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma after 1‑3 Prior Treatments

Fast replyInvestigationalNo placebo
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What is this trial about?

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

The study focuses on adults with multiple myeloma that has returned after treatment or no longer responds to therapy (relapsed or refractory). These patients have previously received a medicine that targets CD38 (anti‑CD38 antibody) and the drug lenalidomide.

Two treatments are being compared. The experimental drug, identified by the code name JNJ-79635322, is a laboratory‑created protein that can bind to three different targets on cancer cells, helping the immune system recognize and attack them. The standard comparator is teclistamab, another laboratory‑created protein that works in a similar way. Both medicines are given as a subcutaneous injection (placed under the skin). The experimental agent is a type of monoclonal antibody, a class of drugs that act like a guided missile for the immune system.

The purpose of the trial is to compare how well the two drugs work in controlling the disease. Participants are randomly assigned to receive either the experimental drug or the comparator, with regular treatment sessions over several months and periodic clinic visits for safety checks and blood testing. The study continues until a predefined period has passed or the disease progresses.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment in the trial

    After signing the consent form, you become a participant in a phase 3 study that compares two treatments for relapsed or refractory multiple myeloma.

  2. Step 2

    Randomization to a treatment group

    The study assigns you randomly to receive either jnj-79635322 (the test drug) or teclistamab (the comparator drug).

    The assignment is done by the study team and you will not know which drug you receive.

  3. Step 3

    Initial medication administration

    You will receive a subcutaneous injection (an injection under the skin) of the assigned medication.

    The dose listed in the study documentation is 0 mg; the exact amount and schedule are defined by the study protocol.

  4. Step 4

    Ongoing treatment visits

    You will continue to receive the assigned medication by subcutaneous injection according to the schedule set by the study protocol.

    Each visit includes the injection and any required safety checks that the study team performs.

  5. Step 5

    Study duration and completion

    The trial is planned to run until the estimated end date of 2032-12-29, unless you stop early for any reason.

    At the final visit, you will undergo the last assessments and the study will be concluded for you.

Who can join the trial?

5 criteria

  • Be at least 18 years old (or the legal age of adulthood) when you give consent to join the study.
  • Have a confirmed diagnosis of multiple myeloma that follows the International Myeloma Working Group (IMWG) rules, and show measurable disease in lab tests, such as a blood M‑protein level of 0.5 g/dL or higher, or a blood level of immunoglobulin free light chains (FLC) of 10 mg/dL or higher with an abnormal kappa/lambda ratio, or a urine M‑protein level of 200 mg in a 24‑hour collection.
  • Have received 1 to 3 previous treatment regimens (called “lines”) for myeloma, and these must have included both an anti‑CD38 antibody (a drug that targets a protein on myeloma cells) and the medicine lenalidomide. You must have taken at least two consecutive treatment cycles of the anti‑CD38 antibody (or at least six doses if it was given as maintenance) and at least two consecutive cycles of lenalidomide, unless the disease got worse during that treatment.
  • The disease must be either “relapsed” (meaning it responded to earlier treatment but then returned at least 60 days after stopping that treatment) or “refractory” (meaning it never responded well or got worse within 60 days after stopping treatment), according to the International Myeloma Working Group response criteria.
  • Your overall health and ability to perform daily activities must be rated as 0, 1, or 2 on the ECOG performance status scale at the screening visit and right before the first dose of the study drug. (A score of 0 means fully active; 2 means able to walk and care for yourself but unable to work.)

Who cannot join the trial?

17 criteria

  • Having a serious infection (viral, fungal, or bacterial) that needs medicines taken throughout the body systemic antiviral, antifungal, or antimicrobial therapy.
  • Having an active autoimmune disease (where the immune system attacks your own body) that required strong immune‑suppressing medicines within the last 6 months, except for vitiligo, type 1 diabetes, or past thyroid disease that is now normal.
  • Having dementia (significant memory loss) or an altered mental state.
  • Having an ongoing blood disorder called myelodysplastic syndrome or any other B‑cell cancer besides multiple myeloma.
  • Having a history of another cancer (not multiple myeloma) that is considered high risk for coming back and would need systemic (whole‑body) therapy.
  • Having an active cancer (other than multiple myeloma) that is getting worse or needed a treatment change in the last 24 months, unless it is a cancer that is considered cured, such as:
    • Non‑muscle invasive bladder cancer that is small and low‑grade.
    • Non‑melanoma skin cancers or localized melanoma removed with surgery.
    • Non‑invasive cervical cancer.
    • Localized breast cancer that was treated and is now stable.
    • Localized prostate cancer (stage M0, N0) with a Gleason score ≤ 7 that was treated locally.
    • Other cancers judged to be cured with very low risk of coming back.
    • Having active hepatitis B infection, shown by a positive test for HBsAg, or having detectable hepatitis B virus DNA; even past hepatitis B requires a negative DNA test before joining.
    • Having active hepatitis C infection, shown by a positive antibody test, unless a follow‑up test shows no virus RNA (no active virus).
    • Having any other active liver disease caused by an infection.
    • Taking any other cancer treatment at the same time, including radiation therapy that is not only for comfort.
    • Having had an allogeneic stem‑cell transplant (stem cells from a donor) less than 6 months ago, or still taking medicines that suppress the immune system, or showing signs of graft‑versus‑host disease, or still having side effects from previous cancer treatment that are worse than mild (greater than Grade 1).
    • Having previously received or currently receiving T‑cell redirecting therapy such as CAR‑T cells or bispecific antibodies that target the proteins BCMA or GPRC5D.
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Investigated drugs

  • teclistamab

    is a medicine given as a small injection under the skin. It works by linking the body’s immune T‑cells to the cancer cells that have a protein called BCMA. By bringing these two cells together, it helps the immune system recognize and kill the myeloma cells. In this study, teclistamab is used as the standard treatment to compare the new drug against.

  • JNJ-79635322

    is an experimental medicine also given as a subcutaneous injection. It is a special type of antibody that can attach to three different targets at once: a protein on T‑cells (CD3), a protein on myeloma cells (BCMA), and another protein (GPRC5D) that is found on many myeloma cells. By binding to all three, it aims to direct the immune system more strongly toward the cancer cells and improve their destruction. In the trial, JNJ‑79635322 is the new therapy being tested to see if it works better than teclistamab.

What is already known about the treatment

  • Teclistamab

    It is given as a subcutaneous injection in a liquid solution. It is an FDA‑approved drug and is described in the medical literature as a bispecific antibody for multiple myeloma. It is used to treat patients whose disease has returned or did not respond to earlier therapies. It works by linking T‑cells to cancer cells through the CD3 and BCMA proteins, prompting the immune system to destroy the tumor; it belongs to the class of bispecific monoclonal antibodies.

  • JNJ‑79635322

    It is administered by subcutaneous injection as a liquid solution. It is still an investigational drug with orphan‑drug status and is being studied in clinical trials for multiple myeloma. It is intended for patients with relapsed or refractory disease after prior treatments. It binds to three targets – CD3 on T‑cells, BCMA and GPRC5D on myeloma cells – to bring immune cells into contact with the cancer and trigger killing; it is classified as a trispecific IgG1 monoclonal antibody.

Investigated diseases

Relapsed or refractory multiple myeloma - A cancer of the blood‑forming cells where abnormal plasma cells build up in the bone marrow. “Relapsed” means the disease has returned after a period of improvement, while “refractory” indicates it does not respond to previous treatments. Over time the number of abnormal cells increases, leading to more bone damage, reduced blood cell production, and possible kidney strain. Symptoms such as bone pain, fatigue, and easy bruising can become more pronounced as the disease advances. The condition continues to evolve until it is effectively controlled or changes in its behavior are observed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523815-12-00Protocol code79635322MMY3002Estimated enrolment700 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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