Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Graft vs Host Disease

Keywords

RuxolitinibT cells

Outcome Measures

Primary Outcomes (1)

Toxicity and maximum tolerated dose
To determine the maximum tolerated dose (MTD) and toxicity of Treg-enriched infusion among patients receiving ruxolitinib.
Up 12 weeks after infusion

Secondary Outcomes (7)

Quantification of targeted cells of manufacturing Treg-enriched product meeting the targeted cell dose-level.
Before 24 hours to infusion up infusion day
Clinical response of Treg-enriched infusion
Up 12 weeks after Treg infusion
Immunologic effects through phenotypical evaluation
Up 12 weeks after Treg infusion
Immunologic effects through immune globulins.
Up 12 weeks after Treg infusion
Immunologic effects through plasma banking
Up 12 weeks after Treg infusion
+2 more secondary outcomes

Study Arms (1)

Regulatory T-cell enriched infusion

EXPERIMENTAL

Dose escalation sequential cohorts Regulatory T-cell enriched infusion (Cells/kg) will be administered. The cohorts will be dose escalated per the schema below: Dose-level A: 0.5 x 10ˆ6 Cells/kg Dose-level B: 1 x 10ˆ6 cell/kg Dose-level C: 2 x 10ˆ6 cell/kg

Biological: Regulatory T-cell enriched infusion

Interventions

Regulatory T-cell enriched infusionBiological

Enrichment of CD25hi regulatory T cells from CD8 and/or CD19 pre-depleted leukapheresis products.

Regulatory T-cell enriched infusion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Recipient of allogeneic hematopoietic stem cell transplantation.
Participants must have steroid-refractory cGVHD and had obtained a partial response after at least 4 weeks of treatment with ruxolitinib.

Sponsors & Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Otherlead

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Seville, 41013, Spain

Related Publications (1)

Soares MVD, Gomez VE, Azevedo RI, Pereira PNG, Velazquez TC, Mendes L, Alho AC, Garcia-Guerrero E, Garcia-Calderon CB, Tharmaratnam K, Cabral IA, Ribeiro AC, Juncal C, Roncon S, Pais AT, Gil AR, Espada E, Rodrigues A, Garcao A, Yaspo ML, Warnatz HJ, Lehrach H, Ward L, Barbosa-Morais NL, Quintas AM, Palmela P, Caldas C, Ferreira R, Leite L, Martins C, Lourenco F, Moreno R, Campilho F, Cheyne CP, Garcia-Finana M, Campos A, Baron F, Arpinati M, Hoffmann P, Edinger M, Koreth J, Ritz J, Vaz CP, Perez-Simon JA, Lacerda JF. Phase 1/2 trials of donor regulatory T cells for the treatment of steroid-refractory chronic graft-versus-host disease. Blood Adv. 2026 May 12;10(9):2904-2915. doi: 10.1182/bloodadvances.2025017996.
PMID: 41637631DERIVED

Study Officials

José Antonio Pérez-Simón, M.D. Ph.D.
Department of Hematology, Hospital Universitario Virgen del Rocío, Sevilla.
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 25, 2018

Study Start

September 25, 2018

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Regulatory T-cell enriched infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Study Arms (1)

Regulatory T-cell enriched infusion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations