Safety and Efficacy of Treg Cell in the Treatment of GVHD

NCT06411184 | Not Yet Recruiting Phase 1

• 1 other identifier: XYFY2024-KL045-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

GVHD

Keywords

Regulatory T-Lymphocytes; GVHD

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events assessed according to NCI-CTCAE v5.0

  Baseline up to 60 days after taking Iguratimod]

Secondary Outcomes (4)

• complete response (CR)

  Month 1, 2, 3 and 4

• partial response (PR)

  Month 1, 2, 3 and 4

• stable disease (SD)

  Month 1, 2, 3 and 4

• progressed disease (PD)

  Month 1, 2, 3 and 4

Study Arms (1)

Regulatory T-Lymphocytes

EXPERIMENTAL

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

Drug: Regulator T Cells

Interventions

Regulator T Cells DRUG

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

Also known as: Regulatory T-Lymphocytes

Regulatory T-Lymphocytes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0\~1.
• Anticipated survival of more than 12 months.
• General criteria:
• Serum pregnancy test negative for women of childbearing age during the screening period.
• Sexually active women of childbearing age participating in this study must agree to contraception during the trial and after the last dose of medication.

You may not qualify if:

• 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.
• Laboratory tests:
• 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).
• Alanine aminotransferase (ALT) \>3 times the upper limit of normal (ULN), aspartate aminotransferase (AST) \>3×ULN (excluding GVHD as the cause).
• Total bilirubin (TBIL) \>1.5×ULN (excluding GVHD as the cause).
• Creatinine clearance CrCl \<60 mL/min (Cockcroft-Gault formula).
• General criteria:
• Pregnant or lactating women.
• History of serious illness or other evidence indicating a serious illness, or any other condition that the investigator believes may make the subject unsuitable for this study.
• History of severe cardiovascular disease \[New York Heart Association (NYHA) functional class III or IV\], including but not limited to ventricular arrhythmias requiring clinical intervention, uncontrolled hypertension (systolic blood pressure ≥160mmHg and/ or diastolic blood pressure ≥100mmHg); within 6 months prior to enrollment, there is unstable angina, acute coronary syndrome, congestive heart failure, stroke, or other cardiovascular events of class III or above; at screening, NYHA functional class ≥II or left ventricular ejection fraction (LVEF) \<50% on echocardiography.
• Unable to take oral medications, with severe (NCI CTCAE v5.0 ≥ grade 3) chronic gastrointestinal dysfunction, the presence of malabsorption syndrome, or any other condition affecting gastrointestinal absorption.
• History of clear neurological or psychiatric disorders (including epilepsy or dementia), currently suffering from psychiatric disorders, or judged by the investigator to be non-compliant and unsuitable for participation in the study.
• History of other severe (NCI CTCAE v5.0 ≥ grade 3) systemic diseases, deemed unsuitable for participation in the clinical trial by the investigator.

Sponsors & Collaborators

• Xuzhou Medical University: lead

Central Study Contacts

Kailin Xu, MD.,PD.

CONTACT

15162166166; lihmd@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 13, 2024

Record last verified: 2024-05