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

NCT02860559 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-10-08

No results posted yet for this study

Summary

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.

Conditions

  • Severe Combined Immunodeficiency

Interventions

BIOLOGICAL

TBX-1400

Hematopoietic stem cells transplantation

Sponsors & Collaborators

  • Taiga Biotechnologies, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2024-02-29
Completion
2024-03-31
FDA Drug
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02860559 on ClinicalTrials.gov