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

Clinical trials are studying Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured in people having haematopoietic stem cell transplantation for blood cancers. These trials aim to check safety and early efficacy, including whether immune cells recover after transplant. The main study is an early phase trial in adults receiving transplantation support.

Table of contents

Trial overview

The available trial is an early phase study of Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured, also called SMART101 in the trial record.[1] It is being studied in the setting of haematopoietic stem cell transplantation for blood cancers.[1]

Who is being studied

The trial focuses on people receiving treatment in haematopoietic stem cell transplantation for blood cancers.[1] The source data do not give a full list of eligibility rules, but the study is clearly tied to the transplant setting.[1]

Trial phase and design

This is a Phase 1/2 interventional study, which means the researchers are testing an active treatment and looking first at safety, dose selection, and early signs of benefit.[1] The brief summary says Segment 1 is used to determine the recommended dose, and Segment 2 then looks at safety and activity.[1]

What is being measured

The main safety endpoint is the occurrence of unexpected unacceptable toxicities within 28 days after SMART101 infusion.[1] Toxicity means harmful effects or serious problems after treatment.[1]

The main efficacy endpoint in Segment 2 is T-cell reconstitution rate, defined as a naïve CD4+ T cell count of at least 50/μL within 100 days after transplant, confirmed again on a later test within 2 months.[1] In simple terms, the study checks whether a specific immune cell type returns after transplant.[1]

Study status and size

The study status is listed as Authorised.[1] The planned enrollment is 59 participants, which means the study aims to include 59 people in total.[1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05768035Phase 1/2Treatment in haematopoietic stem cell transplantation for blood cancersAuthorised59

FAQ

  • What is being studied in these clinical trials? The trials are studying Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured as a treatment given during haematopoietic stem cell transplantation. The main goals are to check safety and to see whether T-cell recovery improves after transplant.
  • Who can take part in the study? The study is focused on people with blood cancers who are undergoing haematopoietic stem cell transplantation. The trial data do not list full eligibility details here, but participation is linked to this transplant setting.
  • What phase is the trial? The trial is a Phase 1/2 study. This means it is early research that first looks at safety and dose, and then also checks early signs of benefit.
  • What condition is the trial targeting? The condition studied is treatment in haematopoietic stem cell transplantation for blood cancers. The trial looks at whether the study treatment can improve transplant outcomes in this setting.
  • What results are the researchers measuring? The study measures unexpected unacceptable toxicities within 28 days after infusion. It also measures T-cell reconstitution, which means recovery of a type of immune cell, by checking for naïve CD4+ T cell counts reaching a set level after transplant.

Ongoing Clinical Trials on Allogeneic T-Cell Precursors, Mobilized Peripheral Blood-Derived, Ex Vivo Cultured

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy

Glossary

  • Allogeneic: Taken from a donor rather than from the patient. In this study, the treatment comes from another person.
  • T-cell: A type of white blood cell that helps fight infection and supports the immune system.
  • Precursors: Early cells that can develop into more mature cells.
  • Mobilized peripheral blood: Blood collected from the bloodstream after the donor has been treated so more stem or immune cells move into the blood.
  • Ex vivo cultured: Cells grown outside the body in a laboratory before they are given to a patient.
  • Haematopoietic stem cell transplantation: A transplant that gives blood-forming stem cells to help rebuild the blood and immune system.
  • Blood cancers: Cancers that affect the blood, bone marrow, or lymph system.
  • Phase 1/2: An early stage of clinical research that checks safety, dose, and early signs that the treatment may work.
  • Safety: How well a treatment is tolerated and whether it causes harmful problems.
  • T-cell reconstitution: The return or recovery of T cells after treatment, especially after a transplant.
  • Naïve CD4+ T cell: A young type of immune T cell that has not yet learned to respond to a germ or threat.
  • Unexpected unacceptable toxicities: Serious or unwanted problems that were not expected and are considered too severe.

References