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NCT02860559
Safety and Early Efficacy Study of TBX-1400 in Patients With Severe Combined Immunodeficiency
Phase 1 trial testing TBX-1400 in Severe Combined Immunodeficiency in 8 participants. Status unknown.
1 February 2024
Quick facts
| Lead sponsor | Taiga Biotechnologies, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 8 |
| Start date | 1 August 2021 |
| Primary completion | 1 February 2024 |
| Estimated completion | 1 March 2024 |
| Sites | 2 locations across Israel |
Drugs / interventions tested
- TBX-1400 — full drug profile →
Conditions studied
- Severe Combined Immunodeficiency — all drugs for Severe Combined Immunodeficiency →
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.
-
Adverse Events following transplant with TBX-1400
Time frame: Two years
Adverse events from subject or parent reporting or other assessments
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):
-
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:
- PubMed search for NCT02860559
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Severe Combined Immunodeficiency
Currently open trials in the same condition.
- NCT05651113 — The Experience of Screening for SCID · recruiting
- NCT03597594 — Haplocompatible Transplant Using TCRα/β Depletion Followed by CD45RA-Depleted Donor Lymphocyte Infusions for Severe Comb · Phase 1, PHASE2 · active not recruiting
- NCT00055172 — Genetic Basis of Immunodeficiency · recruiting
Other Taiga Biotechnologies, Inc. trials
Trials by the same sponsor.
- NCT04709458 — Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis · Phase 1 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02860559 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taiga Biotechnologies, Inc.
- Last refreshed: 6 October 2020
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