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NCT03879876: HTLP Necker

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

Status unknown Phase 1, PHASE2 Last updated 27 September 2022
What this trial tests

Phase 1, PHASE2 trial testing Human T Lymphoid Progenitor (HTLP) injection in Pediatric Patients in 12 participants. Status unknown.

Timeline
13 May 2020
Primary endpoint
3 September 2023
3 June 2025

Quick facts

Lead sponsorAssistance Publique - Hôpitaux de Paris
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date13 May 2020
Primary completion3 September 2023
Estimated completion3 June 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 2 to 18, any sex, with Pediatric Patients or Any Type of Severe Combined Immunodeficiency (SCID). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Immune Reconstitution After Allogeneic Haematopoietic Cell Transplantation: From Observational Studies to Targeted Interventions.
    Yanir A, Schulz A, Lawitschka A, Nierkens S, et al · · 2021 · cited 35× · PMID 35087775 · DOI 10.3389/fped.2021.786017
  2. Physioxia enhances T-cell development ex vivo from human hematopoietic stem and progenitor cells.
    Shin DY, Huang X, Gil CH, Aljoufi A, et al · · 2020 · cited 15× · PMID 32761664 · DOI 10.1002/stem.3259
  3. A DL-4- and TNFα-based culture system to generate high numbers of nonmodified or genetically modified immunotherapeutic human T-lymphoid progenitors.
    Moirangthem RD, Ma K, Lizot S, Cordesse A, et al · · 2021 · cited 11× · PMID 34117371 · DOI 10.1038/s41423-021-00706-8
  4. Stem cell therapies in the clinic.
    Acharya S, Shaha S, Bibbey MG, Mukherji M, et al · · 2025 · cited 3× · PMID 40385529 · DOI 10.1002/btm2.70000
  5. T-Cell Progenitors As A New Immunotherapy to Bypass Hurdles of Allogeneic Hematopoietic Stem Cell Transplantation.
    Gaudeaux P, Moirangthem RD, Bauquet A, Simons L, et al · · 2022 · cited 3× · PMID 35874778 · DOI 10.3389/fimmu.2022.956919
  6. T-lymphoid progenitor-based immunotherapies: clinical perspectives for one and all.
    Gaudeaux P, Moirangthem RD, Paillet J, Martin-Corredera M, et al · · 2022 · PMID 36180781 · DOI 10.1038/s41423-022-00927-5

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Other recruiting trials for Pediatric Patients

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03879876.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing