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NCT03683498: GVHD-TReG

Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-host-Disease

Completed Phase 1 Last updated 23 May 2022
What this trial tests

Phase 1 trial testing Regulatory T-cell enriched infusion in Chronic Graft vs Host Disease in 16 participants. Completed in 24 March 2022.

Timeline
25 September 2018
Primary endpoint
24 March 2022
24 March 2022

Quick facts

Lead sponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsequential
Maskingnone
Primary purposetreatment
Enrollment16
Start date25 September 2018
Primary completion24 March 2022
Estimated completion24 March 2022
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla — full company profile →

Who can join

Eligibility, any sex, with Chronic Graft vs Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase I Trial of Donor Regulatory T-cells for Steroid-Refractory Chronic Graft-versus-Host-Disease in patients who do not obtain complete remission with ruxolitinib

Publications & conference data

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

  1. Opportunities for Treg cell therapy for the treatment of human disease.
    Bluestone JA, McKenzie BS, Beilke J, Ramsdell F. · · 2023 · cited 90× · PMID 37153574 · DOI 10.3389/fimmu.2023.1166135
  2. Regulatory T cells in rheumatoid arthritis: functions, development, regulation, and therapeutic potential.
    Yan S, Kotschenreuther K, Deng S, Kofler DM. · · 2022 · cited 58× · PMID 36173485 · DOI 10.1007/s00018-022-04563-0
  3. Regulatory T Cell Therapy of Graft-versus-Host Disease: Advances and Challenges.
    Hefazi M, Bolivar-Wagers S, Blazar BR. · · 2021 · cited 22× · PMID 34575843 · DOI 10.3390/ijms22189676
  4. Combined treatment of graft versus host disease using donor regulatory T cells and ruxolitinib.
    Rodríguez-Gil A, Escamilla-Gómez V, Nufer M, Andújar-Sánchez F, et al · · 2022 · cited 7× · PMID 35589917 · DOI 10.1038/s41598-022-12407-x
  5. Graft-Specific Regulatory T Cells for Long-Lasting, Local Tolerance Induction.
    Seltrecht N, Hardtke-Wolenski M, Iordanidis K, Jonigk D, et al · · 2024 · cited 4× · PMID 39056797 · DOI 10.3390/cells13141216
  6. Chronic Graft-versus-host Disease, Part 2: Clinical Success and Roadmap to the Future.
    El Jurdi N, Blazar BR, Pavletic SZ. · · 2025 · cited 2× · PMID 39915926 · DOI 10.1097/tp.0000000000005345
  7. The Development of New Agents for Post-Hematopoietic Stem Cell Transplantation Non-Infectious Complications in Children.
    Ilan U, Brivio E, Algeri M, Balduzzi A, et al · · 2023 · cited 2× · PMID 36983151 · DOI 10.3390/jcm12062149
  8. Phase 1/2 trials of donor regulatory T cells for the treatment of steroid-refractory chronic graft-versus-host disease.
    Soares MVD, Gómez VE, Azevedo RI, Pereira PNG, et al · · 2026 · PMID 41637631 · DOI 10.1182/bloodadvances.2025017996

Verify or expand the search:

Other trials of Regulatory T-cell enriched infusion

Trials testing the same drug.

Other recruiting trials for Chronic Graft vs Host Disease

Currently open trials in the same condition.

Other Fundación Pública Andaluza para la gestión de la Investigación en Sevilla trials

Trials by the same sponsor.

Verify against primary sources

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/NCT03683498.

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