Safety and Efficacy Study of Human T Lymphoid Progenitor (HTLP) Injection After Partially HLA Compatible Allogeneic Hematopoietic Stem Cell Transplantation in SCID Patients

  • STATUS
    Recruiting
  • End date
    Jun 3, 2025
  • participants needed
    12
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 25 April 2021

Summary

The purpose of this study is to evaluate the safety and the efficacy of Human T Lymphoid Progenitor (HTLP) injection to accelerate immune reconstitution after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients.

Description

Not provided

Details
Condition Pediatric Patients, Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Any Type of Severe Combined Immunodeficiency (SCID), Partial HLA Incompatible Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Treatment Human T Lymphoid Progenitor (HTLP) injection
Clinical Study IdentifierNCT03879876
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on25 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Pediatric patients affected by any type of SCID confirmed by clinical, immunological and/or molecular diagnosis and eligible for an allogeneic HSCT
Absence of a matched sibling donor or a matched unrelated donor (MUD) 10/10
Clinical conditions incompatible with the search of a MUD
Written, informed consent of parents/ legal representative (child)
Age 2 years at the time of screening
No prior therapy with allogeneic stem cell transplantation
No treatment with another investigational drug within one month before inclusion
Patient affiliated to social security

Exclusion Criteria

Presence of an HLA genoidentical donor
Absence of written parental consent
Treatment with another investigational drug within one month before inclusion
Positive for HIV infection by genome PCR
Contra-indication to allogeneic transplantation or conditioning therapy (except SCID patients with DNA repair deficiency)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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