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Study of LUMC-BOB1-B7-TCR.

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What is this trial about?

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

This clinical trial studies the treatment of blood cancers including Multiple Myeloma, Non-Hodgkin B-cell lymphoma, and B-cell Acute Lymphoblastic Leukemia that have either returned after previous treatment or did not respond to standard treatments. The study uses a new treatment called LUMC-BOB1-B7-TCR.1, which is made from the patient's own immune cells (specifically T cells) that have been modified in a laboratory to better fight cancer cells.

The purpose of this study is to determine if this new cell therapy treatment is safe to use and if it works effectively against these blood cancers. The treatment is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. This is a combined Phase 1 and Phase 2 study, where Phase 1 focuses on finding the right dose of the treatment, and Phase 2 examines how well the treatment works.

The treatment involves taking some of the patient's own immune cells, modifying them in a laboratory to recognize and attack cancer cells, and then returning them to the patient through an infusion. After receiving the treatment, patients will be monitored for side effects and to see how their cancer responds to the therapy. The study specifically looks at patients whose cancer cells have a particular genetic marker called HLA-B*07:02.

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

    Initial verification

    Your eligibility for the trial will be confirmed through HLA-B*07:02 genotyping test

    A blood test will check if you have sufficient CD8+ T cells (a type of immune cell) in your blood

    Your current disease status and medical history will be evaluated

  2. Step 2

    Cell collection

    Your blood cells will be collected through a procedure called leukapheresis

    This collected material will be used to create your personalized treatment

  3. Step 3

    Treatment preparation period

    You must not receive any experimental treatments for 3 months before the infusion

    If you had previous T-cell engaging bispecific antibodies treatment, you must wait 2 months before the infusion

    If you had CAR therapy (a type of cell therapy), you must wait 3 months before the infusion

  4. Step 4

    Treatment administration

    You will receive LUMC-BOB1-B7-TCR.1 through an intravenous infusion (delivered directly into your vein)

    The treatment is given as a single infusion

    The exact dose will be determined based on the phase of the trial

  5. Step 5

    Monitoring period

    You will be monitored for side effects for 28 days after the infusion

    Your response to treatment will be evaluated after 12 weeks

    Follow-up monitoring will continue for up to 2 years after the infusion

    You will need to use effective contraception for 12 months after the infusion

Who can join the trial?

14 criteria

  • Must be at least 18 years old
  • Must have one of these conditions that has returned or is not responding to standard treatments:
    • B-cell Acute Lymphoblastic Leukemia (B-ALL)
    • Multiple Myeloma (MM)
    • Non-Hodgkin B-cell lymphoma
    • Must test positive for a specific genetic marker called HLA-B*07:02
    • Must have an adequate number of CD8 T cells (a type of immune cell) available for treatment, either:
      • From blood samples, or
      • From previously stored blood collection
      • Must have a performance status of 0-3 on the ECOG scale (a measure of daily living abilities)
      • Must be able to understand and sign an informed consent form
      • For women who can become pregnant, must have a negative pregnancy test
      • Both men and women who can have children must agree to use effective birth control during the study and for 12 months after treatment
      • Must not have received:
        • Any experimental treatments in the past 3 months
        • Specific antibody treatments (BsAbs) in the past 6 months
        • CAR therapy (a type of cell therapy) in the past 6 months

Who cannot join the trial?

15 criteria

  • Age under 18 years old
  • Age over 70 years old
  • Not having the specific genetic marker HLA-B*07:02 (a protein on cells that helps the immune system recognize foreign substances)
  • Current active infections
  • Pregnancy or breastfeeding
  • Having diseases other than Multiple Myeloma, Non-Hodgkin B-cell lymphoma, or B-cell Acute Lymphoblastic Leukemia
  • Previous treatment with similar cell therapy in the last 3 months
  • Severe heart, lung, liver, or kidney problems
  • Active autoimmune disease (when your immune system attacks your own body)
  • Participation in other clinical trials within the past 30 days
  • Uncontrolled high blood pressure
  • History of serious allergic reactions to similar treatments
  • Active cancer other than the conditions being studied
  • Serious mental health conditions that could affect participation
  • Unable to provide informed consent
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Investigated drugs

LUMC-BOB1-B7-TCR.1 is a type of cell therapy that uses modified T cells (a type of immune cell). These cells have been engineered to carry a special receptor called BOB1-TCR that helps them recognize and attack cancerous B cells. This therapy is designed to work specifically in patients who have a certain genetic marker (HLA-B*07:02) and are suffering from B-cell cancers that have either come back after treatment or haven't responded to previous treatments.

What is already known about the treatment

LUMC-BOB1-B7-TCR.1 – A novel cell therapy treatment administered through intravenous infusion, specifically designed for patients with B-cell malignancies who are positive for HLA-B*07:02. This therapeutic agent belongs to the class of T-cell receptor (TCR) therapies, which work by modifying patients' T-cells to recognize and target specific proteins expressed by cancer cells. The treatment is currently being investigated in clinical trials for multiple myeloma, non-Hodgkin B-cell lymphoma, and B-cell acute lymphoblastic leukemia, particularly in cases where the disease has relapsed or become resistant to other treatments. The medication acts by enabling modified T-cells to recognize and eliminate cancer cells that express the BOB1 protein, representing a targeted immunotherapy approach in cancer treatment.

Investigated diseases

  • Multiple Myeloma

    A blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. These abnormal plasma cells accumulate in the bone marrow, forming tumors in multiple bones throughout the body. The disease often causes bone pain, weakening of bones, fatigue, and frequent infections.

  • Non-Hodgkin B-cell Lymphoma

    A cancer that starts in B lymphocytes, which are white blood cells that help fight infections. The abnormal B-cells begin to multiply uncontrollably and collect in lymph nodes and other tissues. This causes swelling of lymph nodes and can affect various parts of the body.

  • B-cell Acute Lymphoblastic Leukemia

    A cancer of the blood and bone marrow that affects B lymphocytes, causing them to develop abnormally. The immature B-cells (called blasts) multiply rapidly and crowd out healthy blood cells in the bone marrow. The disease progresses quickly, leading to decreased blood cell counts and affecting the body's ability to fight infections.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-515900-38-00Protocol code1/BOB1Estimated enrolment22 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).