Safety and Efficacy of Treg Cell in the Treatment of GVHD
NCT06411184 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2024-05-13
Summary
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.
Conditions
Interventions
- DRUG
-
Regulator T Cells
Autologous 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
Sponsors & Collaborators
-
Xuzhou Medical University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2025-12-31
- Completion
- 2027-05-31
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