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

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oncopole Claudius Regaud	Toulouse	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Ospedale San Raffaele S.r.l.	Milan	Italy
Centre Hospitalier Lyon Sud	Pierre Benite	France
Acemweqxyu Pkprqxmc Hmbqaxhc Do Pzorl	Paris	France
Culn Dc Nxqdu	Vandoeuvre Les Nancy	France
Idclmbdh Pjqhmsvoivvwqzr Cfuyoj Cbozdt	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2023
Italy	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured

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.

Investigated diseases:

Allogenic stem cell transplantation

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 ID:

2024-517953-28-00

Protocol code:

SI101-02

NCT ID:

NCT05768035

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?