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NCT02860559

Safety and Early Efficacy Study of TBX-1400 in Patients With Severe Combined Immunodeficiency

Status unknown Phase 1 Last updated 6 October 2020
What this trial tests

Phase 1 trial testing TBX-1400 in Severe Combined Immunodeficiency in 8 participants. Status unknown.

Timeline
1 August 2021
Primary endpoint
1 February 2024
1 March 2024

Quick facts

Lead sponsorTaiga Biotechnologies, Inc.
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment8
Start date1 August 2021
Primary completion1 February 2024
Estimated completion1 March 2024
Sites2 locations across Israel

Drugs / interventions tested

Conditions studied

Sponsor

Taiga Biotechnologies, Inc. — full company profile →

Who can join

Adults 1 Month to 4, any sex, with Severe Combined Immunodeficiency. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

This is a study of stem cell transplantation with TBX-1400 in pediatric subjects with severe combined immunodeficiency (SCID). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-1400 is safe. The second goal is to find out what effects TBX-1400 stem cells have on time to engraftment in pediatric subjects with SCID. The study hypothesis is that TBX-1400 cells will shorten the time to immune reconstitution after transplant.

Publications & conference data

1 peer-reviewed publication 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

Verify or expand the search:

Other recruiting trials for Severe Combined Immunodeficiency

Currently open trials in the same condition.

Other Taiga Biotechnologies, Inc. trials

Trials by the same sponsor.

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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/NCT02860559.

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