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Study on the Safety and Effectiveness of SMART101 for Patients Undergoing Stem Cell Transplantation for Blood Cancers

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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 improving treatments for patients with certain types of blood cancers, specifically those who undergo a procedure called hematopoietic stem cell transplantation. The study is testing a new treatment called SMART101, which is a type of cell therapy. This therapy involves using specially prepared cells, known as allogeneic T-cell precursors, which are derived from blood and grown in a laboratory setting. These cells are then given to patients through an intravenous infusion to help improve the outcomes of the transplantation process.

The purpose of the study is to evaluate the safety and effectiveness of SMART101 in patients who have received a stem cell transplant from a donor whose tissue type does not completely match their own. The study will be conducted in two segments. In the first segment, researchers will determine the best dose of SMART101 to use. In the second segment, they will assess how safe the treatment is and how well it works in helping the immune system recover, particularly focusing on the reconstitution of CD4+ T-cells, which are important for fighting infections.

Participants in the study will receive the SMART101 treatment after their stem cell transplant, along with a medication called cyclophosphamide, which is used to help prevent complications. The study will monitor participants for any unexpected side effects and measure how well their immune system recovers over time. The goal is to find out if SMART101 can make stem cell transplants safer and more effective for patients with blood cancers.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign a written informed consent form. This document confirms your voluntary participation and understanding of the study procedures.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure eligibility. This includes checking your age, health status, and specific medical conditions related to blood cancers.

    Tests will be performed to evaluate your heart, lung, liver, and kidney functions. Women of childbearing potential will undergo a pregnancy test.

  3. Step 3

    Preparation for treatment

    Before receiving the treatment, you will undergo a procedure called hematopoietic stem cell transplantation (HSCT). This involves receiving stem cells from a donor whose tissue type is not an exact match to yours.

    You will receive a medication called cyclophosphamide after the transplant to help prevent complications.

  4. Step 4

    Administration of SMART101

    You will receive an infusion of a product called SMART101. This is a cell suspension for injection administered through an intravenous infusion.

    The goal is to determine the recommended dose and evaluate the safety and effectiveness of SMART101 in improving transplantation outcomes.

  5. Step 5

    Monitoring and follow-up

    After the infusion, you will be monitored for any unexpected side effects or toxicities for 28 days.

    Regular follow-up visits will be scheduled to assess your immune system recovery, specifically the reconstitution of T-cells and other immune cells, at various time points such as 30, 60, and 100 days, and at 4, 5, 6, 9, and 12 months post-transplant.

  6. Step 6

    Long-term evaluation

    The study will continue to evaluate your health outcomes, including the incidence of infections, survival rates, and any relapse of the disease, up to 24 months after the transplant.

    Imaging tests, such as MRI, may be conducted to assess the condition of your thymus, an organ involved in immune function.

Who can join the trial?

9 criteria

  • Patients and donors must provide written informed consent. This means they must sign a document agreeing to participate in the study.
  • Patients must have one of the following conditions: AML (Acute Myeloid Leukemia), ALL (Acute Lymphoblastic Leukemia), or MDS (Myelodysplastic Syndromes) and be eligible for a type of stem cell transplant called allogeneic HSCT with a HLA-mismatched donor. This means the donor is not a perfect match but is close enough to be considered safe.
  • Patients must be at least 18 years old at the time of signing the consent form.
  • Patients must have a Karnofsky index of 70% or higher. This is a score that measures a patient's ability to perform everyday activities.
  • Patients must have a left ventricular ejection fraction of 40% or higher. This measures how well the heart is pumping blood.
  • Patients must have healthy lung function or a DLCO (Diffusing capacity of the Lungs for Carbon Monoxide) of 45% or higher. This measures how well the lungs are working.
  • Patients must have adequate liver and kidney function, as shown by standard lab tests. This includes specific levels for bilirubin, AST and ALT (liver enzymes), alkaline phosphatase, and serum creatinine (a kidney function marker).
  • Women who can have children must have a negative pregnancy test and agree to use effective birth control methods for at least one year after the last dose of cyclophosphamide, a medication used in the study. They must also agree not to donate eggs or breastfeed for a specified period.
  • Men who are sexually active must agree to use effective birth control methods with their partners for at least six months after the last dose of cyclophosphamide or one year after the last dose of Thiotepa, if applicable. They must also agree not to donate sperm or father a child within this time frame.

Who cannot join the trial?

5 criteria

  • Patients who have not undergone a **haematopoietic stem cell transplantation**. This is a procedure where stem cells are used to replace damaged or destroyed bone marrow.
  • Patients who are not within the age range of 3 to 4 years old.
  • Patients who are not part of the specific clinical trial group being studied.
  • Patients who are not male or female, as both genders are included in the study.
  • Patients who are not considered part of a **vulnerable population**. This term refers to groups who may be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain health conditions.
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Investigated drugs

  • SMART101

    is a new treatment being tested in this clinical trial. It is designed to help patients who have received a stem cell transplant from a donor who is not a perfect match. The goal of SMART101 is to improve the recovery of the immune system, specifically by helping a type of white blood cell called CD4+ T-cells to grow back after the transplant. This is important because these cells play a crucial role in fighting infections and keeping the body healthy after a transplant.

  • Cyclophosphamide

    is a medication used in this trial after the stem cell transplant. It is given to help prevent a serious complication called graft-versus-host disease (GVHD), where the new immune cells from the donor attack the patient's body. Cyclophosphamide works by suppressing the immune system to reduce the risk of this complication, making the transplant process safer for the patient.

What is already known about the treatment

SMART101 – SMART101 is administered as part of a treatment process for patients undergoing hematopoietic stem cell transplantation, specifically after a type of transplant called HLA-mismatched peripheral blood stem cell transplantation. This medication is currently being studied in clinical trials to determine its safety and effectiveness, particularly in helping the immune system recover by increasing CD4+ T-cells, which are important for fighting infections. SMART101 works at the molecular level by targeting specific pathways to support immune cell growth and function. It is classified under pharmacological agents used in stem cell transplantation therapies.

Investigated diseases

Graft-versus-Host Disease (GvHD) – Graft-versus-Host Disease is a condition that can occur after a hematopoietic stem cell transplantation, where the donated bone marrow or peripheral blood stem cells view the recipient's body as foreign and attack it. The disease typically progresses in two forms: acute and chronic. Acute GvHD usually develops within the first 100 days post-transplant and primarily affects the skin, liver, and gastrointestinal tract. Chronic GvHD can occur later and may involve multiple organs, leading to symptoms such as skin rashes, liver dysfunction, and digestive issues. The severity of GvHD can vary, with some cases being mild and others more severe, potentially affecting the quality of life. The progression of GvHD depends on various factors, including the degree of mismatch between donor and recipient tissues and the immune response.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2024-517953-28-00Protocol codeSI101-02Estimated enrolment59 patientsSponsorSmart Immune

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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).