Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib

NCT ID: NCT05095649

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2026-02-15

Brief Summary

Phase II clinical trial to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission under treatment with ruxolitinib

Detailed Description

A number of 15 patients will be included to assess the efficacy of donor regulatory enriched T cells in steroid-refractory chronic graft versus host disease patients who did not obtain complete remission after 12 weeks of treatment with ruxolitinib.

The doses of Treg-enriched cells will be 2x10^6 cells/kg.

Survival at 1 year after Treg infusion will be represented based on the clinical data with Kaplan Meier curves.

Conditions

Chronic Graft vs Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Regulatory T-cell enriched infusion

The doses of Regulatory T-cell enriched infusion will be 2x10\^6 cells/kg

Group Type: EXPERIMENTAL

Regulatory T-cell enriched infusion

Intervention Type: BIOLOGICAL

Enrichment of cluster of differentiation 25hi regulatory T cells from cluster of differentiation antigen 8 and/or cluster of differentiation antigen19 pre-depleted leukapheresis products.

Interventions

Regulatory T-cell enriched infusion

Enrichment of cluster of differentiation 25hi regulatory T cells from cluster of differentiation antigen 8 and/or cluster of differentiation antigen19 pre-depleted leukapheresis products.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Recipient of allogeneic hematopoietic stem cell transplantation
• Participants must have steroid-refractory cGVHD and had obtained any response other than progression after at least 12 weeks of treatment with ruxolitinib. Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks (or equivalent dosing of alternate glucocorticoids) without complete resolution of signs and symptoms.
• Stable dose of glucocorticoids for 4 weeks prior to enrollment.
• No addition or subtraction of other immunosuppressive medications (e.g., calcineurin-inhibitors, sirolimus, mycophenolate-mofetil) for 4 weeks prior to enrollment. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug.
• No age limit. In the case of children participating in the study, the informed consent will be signed by a parents or legal guardians.
• Eastern Cooperative Oncology Group scale performance status 0-2
• Participants must have adequate organ function
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

• Ongoing prednisone requirement >1 mg/kg/day (or equivalent).
• Concurrent use of calcineurin-inhibitor plus sirolimus (either agent alone is acceptable).
• History of active thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic thrombocytopenic purpura in the last 6 months.
• New immunosuppressive medication in the 4 weeks prior to enrollment.
• Extra-corporeal Photopheresis or rituximab therapy in the 4 weeks prior to enrollment.
• Post-transplant exposure to T-cell or interleukin-2 targeted medication within 100 days prior to enrollment.
• Donor lymphocyte infusion within 100 days prior to enrollment.
• Active malignant relapse.
• Active uncontrolled infection.
• Organ transplant (allograft) recipient.
• HIV-positive individuals on combination antiretroviral therapy are ineligible.
• Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after hematopoietic stem cell transplant.
• Other investigational drugs within 4 weeks prior to enrollment, unless cleared by the Principal Investigator.
• Pregnant women are excluded from this study.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José Antonio Pérez-Simón, M.D. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Hospital Universitario Virgen del Rocío, Sevilla.

Locations

José Antonio Pérez Simón

Seville, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

José Antonio Pérez-Simón, M.D. Ph.D

Role: CONTACT

josea.perez.simon.sspa@juntadeandalucia.es

955013414 ext. 0034

Clara M. Rosso, M.D. Ph.D

Role: CONTACT

claram.rosso.sspa@juntadeandalucia.es

955013414 ext. 0034

Facility Contacts

José Antonio Pérez Simón, PhD

Role: primary

josea.perez.simon.sspa@juntadeandalucia.es

Other Identifiers

Treg4GVHD

Identifier Type: -

Identifier Source: org_study_id