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Study of Durbactagene Autoleucel and Drug Combination for Adults with Relapsed and Refractory Multiple Myeloma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a treatment for adults with relapsed and refractory multiple myeloma, a type of blood cancer that affects plasma cells in the bone marrow. The treatment being tested is called darcabtagene autoleucel, which involves using a patient's own T-cells, a type of white blood cell, that are modified to better recognize and attack cancer cells. These modified cells are known as CAR-T cells, specifically designed to target a protein called B-cell maturation antigen (BCMA) found on the surface of multiple myeloma cells.

The purpose of the study is to evaluate how effective this treatment is in helping patients respond to their disease. Participants in the study will receive the CAR-T cell therapy through an intravenous infusion, which means the treatment is delivered directly into the bloodstream. The study will monitor participants over a period to see how their disease responds to the treatment and to observe any side effects or changes in their condition.

In addition to the main treatment, some participants may also receive other medications such as Bendamustine, Fludarabine Phosphate, Cyclophosphamide, and Tocilizumab to support the therapy or manage side effects. These medications are commonly used in cancer treatment and work in different ways to help control the disease or reduce inflammation. The study aims to gather information on the overall response to the treatment, including how long the response lasts and any potential improvements in the quality of life for participants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, previous treatments, and current health status.

    Eligibility criteria include being 18 years or older, having relapsed and refractory multiple myeloma, and having received at least three prior lines of therapy.

  2. Step 2

    Leukapheresis procedure

    A leukapheresis procedure is performed to collect non-mobilized cells. This is necessary for the manufacturing of the personalized treatment.

  3. Step 3

    Pre-treatment phase

    Before receiving the main treatment, medications are administered to prepare the body. These include bendamustine, fludarabine phosphate, and cyclophosphamide, all given intravenously.

    The purpose of these medications is to reduce the number of existing immune cells, making room for the new treatment.

  4. Step 4

    Administration of durcabtagene autoleucel

    The main treatment, durbacagene autoleucel, is administered through an intravenous infusion. This involves the introduction of modified T-cells designed to target and attack cancer cells.

    This step is crucial as it involves the personalized therapy aimed at treating the multiple myeloma.

  5. Step 5

    Monitoring and follow-up

    After the administration of the treatment, regular monitoring is conducted to assess the response and manage any side effects.

    Follow-up includes checking for the best overall response, time to response, and duration of response, among other measures.

  6. Step 6

    Management of side effects

    If necessary, tocilizumab is administered intravenously to manage specific side effects related to the treatment.

    Continuous monitoring ensures that any adverse events are addressed promptly.

  7. Step 7

    Long-term evaluation

    The study includes long-term evaluation to determine the overall survival and progression-free survival.

    This phase involves periodic assessments to track the effectiveness and safety of the treatment over time.

Who can join the trial?

10 criteria

  • Must be at least 18 years old at the time of signing the consent form.
  • Must be an adult with relapsed and refractory multiple myeloma, which means the disease has returned and does not respond to treatment.
  • Must have received at least three previous treatments for multiple myeloma, including:
    • An IMiD (a type of drug, like lenalidomide or pomalidomide).
    • A proteasome inhibitor (another type of drug, like bortezomib or carfilzomib).
    • An approved anti-CD38 antibody (a specific kind of treatment, like daratumumab or isatuximab).
    • Must show evidence of disease progression, meaning the disease is getting worse, according to specific criteria.
    • Must be refractory to the last treatment, meaning the disease worsened during or within 60 days after the last treatment.
    • Must have a measurable disease at the time of joining the study, as defined by the study rules.
    • Must have an ECOG performance status of 0 or 1, which means the patient is fully active or has some symptoms but can still do light work.
    • Must have a sample of non-mobilized cells accepted for manufacturing, which involves collecting certain cells from the blood.

Who cannot join the trial?

8 criteria

  • Patients who have not experienced a return or worsening of their multiple myeloma after treatment.
  • Patients who are not adults.
  • Patients who are not able to understand or agree to the study requirements.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have had certain treatments recently that might affect the study results.
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Investigated drugs

Ducabtagene Autoleucel is a type of therapy that uses the patient's own immune cells to fight cancer. In this trial, it is used to treat adults with multiple myeloma, a type of blood cancer. The therapy involves modifying the patient's T-cells, a kind of white blood cell, to better recognize and attack cancer cells. This is done by directing the T-cells to target a specific protein found on the surface of the cancer cells, known as B-cell maturation antigen (BCMA). The goal of this treatment is to improve the patient's response to the disease.

What is already known about the treatment

Darcabtagene Autoleucel – This medication is administered as an infusion, specifically designed for adult patients with relapsed and refractory multiple myeloma. It is currently being studied in clinical trials to assess its effectiveness in treating this condition. The main therapeutic indication is for patients who have not responded to other treatments for multiple myeloma. At the molecular level, it works by using genetically modified T-cells to target and destroy cancer cells that express the B-cell maturation antigen (BCMA). It is classified as a CAR-T cell therapy, which is a type of immunotherapy that harnesses the body's immune system to fight cancer.

Investigated diseases

Multiple Myeloma – Multiple myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In this disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins that can cause damage to bones and other organs. As the disease progresses, it can lead to symptoms such as bone pain, frequent infections, anemia, and kidney problems. The disease often goes through periods of remission and relapse, where symptoms may improve and then worsen again. Over time, the accumulation of abnormal cells can crowd out healthy blood cells, leading to further complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507140-37-00Protocol codeCPHE885B12201Estimated enrolment151 patientsSponsorNovartis Pharma AG

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