Safety and Efficacy of Treg Cell in the Treatment of GVHD
ConditionGVHD
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorXuzhou Medical University
About this trial
This is a randomized, single-center phase 1/2a clinical trial without blinding. Regulatory T cells (Tregs) have shown potential in treating various immune-related diseases, including autoimmune disorders, transplant rejection, and inflammatory diseases. The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years who have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), regardless of gender.
Those with persistent manifestations of graft-versus-host disease (GVHD) and suitable for systemic treatment.
Previously received at least 1 but not more than 5 lines of systemic treatment for GVHD.
Corticosteroid therapy dose stable for the two weeks before screening; or, if taking prednisone or an equivalent dose of other corticosteroids at a dose >0.5mg/kg/day for four weeks, with ongoing GVHD manifestations and no improvement; or, if two attempts to taper steroids to a lower dose have failed, and it is necessary to increase the prednisone dose to >0.25mg/kg/day or an equivalent dose.
Disqualifiers
Patients who have received experimental treatment for systemic GVHD within the 28 days prior to enrollment, which was effective and could completely alleviate immunosuppression.
Blood cancer relapse (according to the corresponding criteria for relapse of the primary blood cancer) or post-transplant lymphoproliferative disease at the time of screening.
Absolute neutrophil count (ANC) <1.5×10^9/L (excluding GVHD as the cause).
Platelet count <50×10^9/L (excluding GVHD as the cause).
Trial design
Design model
Single group
Treatments tested in this trial
Regulator T Cells
DrugAutologous Regulatory T-Lymphocytes 1\*10\^6/kg, 2\*10\^6/kg, 4\*10\^6/kg and 8\*10\^6/kg, respectively until restrictive toxic reaction occurs
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Regulatory T-LymphocytesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse events
Adverse events assessed according to NCI-CTCAE v5.0
Time frame
Baseline up to 60 days after taking Iguratimod]Secondary outcomes
1
complete response (CR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Time frame
Month 1, 2, 3 and 42
partial response (PR)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Time frame
Month 1, 2, 3 and 43
stable disease (SD)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Time frame
Month 1, 2, 3 and 44
progressed disease (PD)
Assessment of CR at Month 1, 2, 3 and 4. According to the CHRONIC GVHD ACTIVITY ASSESSMENT - CLINICIAN recorded in NIH Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group report. (Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99.)
Time frame
Month 1, 2, 3 and 4Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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