Immunotherapy with Autologous Tregs in T1DM

NCT06708780 | Recruiting Phase 1 DMC

• 1 other identifier: 2021-427-TREG
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Participants with adverse events, laboratory abnormalities and other signs of toxicity.

  From enrollment to the end of treatment at 1 year

Secondary Outcomes (1)

• Therapeutic effects on diabetes-related outcomes

  From enrollment to the end of treatment at 1 year

Study Arms (2)

Treg Group

EXPERIMENTAL

Participants in this group are transplanted with expanded autologous Tregs in addition to routine therapy for T1DM.

Biological: Ex vivo Expanded Human Autologous Regulatory T Cells; Other: Routine Care

Control Group

OTHER

Participants in this group receive only routine therapy for T1DM.

Other: Routine Care

Interventions

Ex vivo Expanded Human Autologous Regulatory T Cells BIOLOGICAL

Peripheral blood component donation is used to collect Treg cells for ex vivo expansion, with technical guidance provided by the Center for Biotechnology Drug Development at the Shanghai Institute of Materia Medica, Chinese Academy of Sciences.

Treg Group

Routine Care OTHER

Routine care is provided to all participants according to clinical guidelines for T1DM.

Control Group; Treg Group

Eligibility Criteria

• Age: 8 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
• Aged 8 to 65 years;
• At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
• Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

You may not qualify if:

• The condition of diabetic ketoacidosis has not been controlled;
• Severe allergic constitution;
• Known or suspected tumor;
• Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
• Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
• Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
• Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
• According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Shanghai Institute of Materia Medica, Chinese Academy of Sciences: collaborator

Study Sites (1)

The Department of Endocrinology, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dr. Lu, MD

CONTACT

0086-025-868182432; lujing@njglyy.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: November 27, 2024
• Study Start: April 12, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)