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NCT Number: NCT05768035

Safety and Efficacy of SMART101 in Adult Patients With Hematological Malignancies After Haploidentical HSCT With Post-transplant Cyclophosphamide

The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitors (HTLP)) injection to accelerate immune reconstitution after haploidentical hematopoietic stem cell transplantation (HSCT) with post-transplant cyclophosphamide (PT-Cy) in adult patients with hematological malignancies.

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Key information

Conditions

Hematological Malignancies Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Multiple Sulfatase Deficiency Disease Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses Sulfatidosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institut Paoli Calmettes, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Patients with AML, ALL or MDS eligible for an allogeneic HSCT with a haploidentical donor with post-transplant cyclophosphamide.
  • Patients must be ≥ 18 years of age at the time of signing the ICF.
  • Patients must have a Karnofsky index ≥ 70%.
  • Patients must have a left ventricular ejection fraction of ≥40%.
  • Patients must have an intact pulmonary function or Diffusing capacity of the Lungs for Carbon Monoxide (DLCO) ≥ 45% of predicted.
  • Patients must have adequate hepatic and renal functions, as assessed by standard laboratory criteria.

Main Exclusion Criteria:

  • Patients who have received prior allogeneic stem cell transplantation.
  • Patients who have received prior treatment with another cellular therapy within 4 weeks before the planned day of SMART101 infusion.
  • Patients who plan to receive, are concurrently receiving or have received any investigational agent within 4 weeks before the planned day of SMART101 infusion.

Treatment and study plan

Allogeneic T cell progenitors, cultured ex-vivo

Biological

Injection of T cell progenitors 6 days after haplo HSCT and 2 days after the last administration of cyclophosphamide

Other names: SMART101

Primary outcomes

  1. Occurrence of Unexpected Unacceptable Toxicities (UUT) following the administration of SMART101.

    Time frame: 14 days post SMART101 infusion

    To evaluate the safety of SMART101.

  2. CD4+ T cell count.

    Time frame: 100 days post-HSCT

    to evaluate the efficacy of the study drug

Secondary outcomes

  1. Occurrence of adverse events (AEs)

    Time frame: up to 24 months post-HSCT

  2. T cell immune reconstitution

    Time frame: up to 12 months post-HSCT

    Time course of the T cell immune reconstitution, with a focus on naive CD4+ cells and total CD8+cells

  3. Cumulative incidence of infections

    Time frame: Day 100, and Months 6 and 12 post-HSCT

  4. Non-relapse mortality (NRM)

    Time frame: Day 100, and Months 6, 12 and 24 post-HSCT

Other outcomes

  1. Overall Survival (OS)

    Time frame: Month 24 post-HSCT

  2. Disease-free Survival

    Time frame: Month 24 post-HSCT

Study contacts

Contact information is provided by the study sponsor or research team.

Aurélie BAUQUET, PhD

CONTACT

[email protected]

Frédéric LEHMANN, MD

CONTACT

[email protected]

+32 (0) 492 46 23 55

Sponsors and collaborators

Lead sponsor

Smart Immune SAS

Industry

Registry information

Official study title

An Open-label, Multi-center Phase I/II Study to Assess the Safety and the Efficacy of SMART101 After Haploidentical Peripheral Blood Stem Transplantation With Post-transplant Cyclophosphamide in Subjects With Hematological Malignancies

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 14, 2023
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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