Study on the Safety and Effectiveness of SMART101 for Children and Adults with Blood Cancers After T Cell Depleted Stem Cell Transplant

Sponsor: Smart Immune SAS

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04959903

Provider View

This clinical trial is testing a new treatment called SMART101 to see if it can safely and effectively help rebuild the immune system in children and adults who have had a specific type of stem cell transplant for blood cancers.

Patient Parameters

Program Overview

The aim of this study is to evaluate whether SMART101, a type of injection that helps grow new immune cells, can safely and effectively speed up the recovery of the immune system in both children and adults who have undergone a T cell depleted allogeneic hematopoietic stem cell transplant (HSCT) for blood cancers.

Eligibility Criteria

Inclusion Criteria

Group A (Adults):

  • Adults with certain types of blood cancers, such as:
    • Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) that is high risk or has returned after treatment.
    • Myelodysplastic Syndrome (MDS) with specific high-risk features.
  • Eligible for a T cell depleted stem cell transplant.
  • Aged 18 years or older.
  • In good health to undergo a stem cell transplant.
  • Have normal organ function before starting the treatment.

Group B (Children):

  • Children with certain types of blood cancers, such as:
    • Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) that is high risk or has returned after treatment.
  • Eligible for a T cell depleted stem cell transplant.
  • Under 18 years old.
  • Do not have a matched sibling donor.
  • In good health to undergo a stem cell transplant.
  • Have normal organ function before starting the treatment.

Exclusion Criteria

Groups A and B:

  • Use of a specific type of donor, such as a perfectly matched cord blood or a half-matched donor.
  • Previous treatment with a stem cell transplant from another person.
  • Received another type of cell therapy within one month before joining the study.

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