Donor Regulatory T-cells for cGVHD in Patients Who do Not Obtain Complete Remission With Ruxolitinib (Treg4GVHD)

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase

Enrolling

Phase 2

Conditions

Chronic Graft vs Host Disease

Treatments

Biological: Regulatory T-cell enriched infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT05095649

Treg4GVHD

Details and patient eligibility

About

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

Full 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.

Enrollment

15 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.