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Study on the Safety and Effectiveness of SLAMF7 CAR-T Cells for Patients with 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 clinical trial is focused on studying a type of blood cancer called multiple myeloma. The study is testing a new treatment using genetically modified cells known as SLAMF7 CAR-T cells. These are special cells taken from the patient's own body, which are then altered in a lab to help them better fight cancer. The cells are modified to target a specific protein found on the surface of cancer cells, known as SLAMF7, and are then reintroduced into the patient's body through an injection.

The purpose of this study is to determine if this treatment is safe and effective for patients with multiple myeloma. The study is divided into two phases. In the first phase, the focus is on assessing the safety of the treatment and finding the best dose to use in the second phase. The second phase will evaluate how well the treatment works in reducing the cancer. Participants will receive the treatment and be monitored over time to see how their bodies respond. This includes checking for any side effects and measuring the treatment's impact on the cancer.

Throughout the study, participants will have regular check-ups to monitor their health and the progress of the treatment. The study aims to provide valuable information on the potential of SLAMF7 CAR-T cells as a treatment option for multiple myeloma, offering hope for improved outcomes in the future. The trial is expected to continue until 2027, allowing researchers to gather comprehensive data on the long-term effects and benefits of this innovative therapy.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    A blood test is performed to ensure the absence of pregnancy in female patients of childbearing potential.

  2. Step 2

    Treatment preparation

    Preparation for treatment involves the collection of autologous T-cells from the patient. These cells are then modified in a laboratory to target multiple myeloma cells.

    The modified cells are known as SLAMF7 CAR-T cells.

  3. Step 3

    Treatment administration

    The SLAMF7 CAR-T cells are administered through an intravenous infusion. The dosage varies, with options including 3x105 cells/mL, 1x106 cells/mL, 1x104 cells/mL, 1x105 cells/mL, and 3x104 cells/mL.

    The infusion is given as a suspension for injection.

  4. Step 4

    Monitoring and follow-up

    After the infusion, regular monitoring is conducted to assess safety and response to treatment. This includes checking for any adverse effects and measuring the effectiveness of the treatment.

    Follow-up visits are scheduled at various intervals: Days 1, 3, 7, 10, 14, 21, 28, Weeks 6, 8, 12, and Months 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, and 24.

  5. Step 5

    Evaluation of treatment response

    The response to the treatment is evaluated using specific criteria for multiple myeloma. This includes measuring the overall response rate and checking for any signs of disease progression.

    Patient-reported outcomes are also collected to assess the impact of the treatment on quality of life.

Who can join the trial?

9 criteria

  • The patient must sign a form that shows they understand the study and agree to participate.
  • The patient must be at least 18 years old.
  • The patient must be willing and able to follow the study's rules and requirements.
  • The patient must have been diagnosed with **multiple myeloma** and have received at least two previous treatments. These treatments should include high-dose chemotherapy with a transplant of their own stem cells, if eligible, and exposure to specific drugs used for this condition.
  • The patient must have at least one measurable sign of the disease, such as a certain level of **M-protein** in the blood or urine, an abnormal level of **free light chains** in the blood, a proven **plasmacytoma** (a type of tumor), or a certain percentage of **plasma cells** in the bone marrow.
  • The patient can have been treated with an anti-SLAMF7 antibody before.
  • The patient must have a **Karnofsky performance status** of 60% or higher, which is a way to measure their ability to perform daily activities. If the status is lower due to a specific injury but the patient is otherwise fit, they may still be eligible.
  • Female patients who can have children must have a negative pregnancy test and agree to use effective birth control methods or abstain from heterosexual contact during the study and for one year after treatment. They must also agree not to breastfeed during this time.
  • Male patients must agree to use a condom during sexual contact with a pregnant woman or a woman who can have children for at least one year after treatment, even if they have had a vasectomy.

Who cannot join the trial?

5 criteria

  • Patients who have a different condition than multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects certain cells in the bone marrow.
  • Patients who are not within the specified age range cannot participate. The age range for this trial is typically adults.
  • Patients who are not part of the specified clinical trial group cannot participate. This means the trial is looking for specific characteristics in participants.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups who might be at higher risk or need special protection.
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Investigated drugs

SLAMF7 CAR-T cells are a type of treatment used in this clinical trial for patients with multiple myeloma, a type of blood cancer. These are specially modified cells taken from the patient's own immune system. They are engineered to better recognize and attack cancer cells. The goal of using SLAMF7 CAR-T cells is to determine if they are safe and effective in treating multiple myeloma by assessing their ability to reduce or eliminate cancer cells in the body.

What is already known about the treatment

SLAMF7 CAR-T cells – This medication is administered through an infusion, where a patient's own T cells are modified to target and destroy cancer cells. It is currently in clinical trials, specifically in Phase I/IIa, to evaluate its safety and effectiveness in treating multiple myeloma. The main therapeutic indication is for patients with multiple myeloma, a type of blood cancer. At the molecular level, SLAMF7 CAR-T cells work by recognizing and binding to the SLAMF7 protein on the surface of myeloma cells, leading to their destruction. This treatment falls under the category of immunotherapy, which uses 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 kind of white blood cell found in the bone marrow. These abnormal plasma cells multiply rapidly, leading to an overproduction of a single type of antibody, which can cause damage to bones, kidneys, and the immune system. As the disease progresses, it can lead to bone pain, fractures, anemia, and increased susceptibility to infections. The accumulation of myeloma cells in the bone marrow can also interfere with the production of normal blood cells. Over time, the disease can cause significant damage to various organs and systems in the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-512643-23-00Protocol codeCARAMBA-1Estimated enrolment33 patientsSponsorUniversitaetsklinikum Wuerzburg AöR

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