A Clinical Study to Evaluate the Safety and Efficacy of RGB-5088 in Patients With Type 2 Diabetes Mellitus

NCT07794254 | Not Yet Recruiting Phase 1

• 1 other identifier: RGB-5088-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I clinical trial is a multi-center, single-arm, open-label study aimed at evaluating the safety and efficacy of RGB-5088 islet cell infusion in patients with Type 2 Diabetes Mellitus.

Conditions

Diabete Mellitus; Diabete Type 2

Outcome Measures

Primary Outcomes (3)

• Safety as assessed by number of subjects with adverse events

  From RGB-5088 transplantation to one year later

• Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%

  On Day180 post RGB-5088 transplantation

• Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%

  On Day365 post RGB-5088 transplantation

Secondary Outcomes (3)

• Safety as assessed by number of subjects with adverse events

  From RGB-5088 transplantation to end of study (up to 5 years)

• Proportion of subjects who are insulin independent

  From 90 days to end of study (up to 5 years)

• Proportion of subjects achieving HbA1c <7.0% or a reduction from baseline ≥1%

  Up to 5 years post RGB-5088 transplantation

Study Arms (1)

RGB-5088

EXPERIMENTAL

Transplantation under the anterior rectus sheath

Biological: RGB-5088

Interventions

RGB-5088 BIOLOGICAL

Transplantation under the anterior rectus sheath

RGB-5088

Eligibility Criteria

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

You may qualify if:

• Age 18-65 years (inclusive), male or female.
• Diagnosis of type 2 diabetes mellitus (T2DM) with a disease duration ≥5 years.
• Body mass index (BMI) 18-30 kg/m².
• Glycated hemoglobin (HbA1c) 7.0%-10.0%.
• Adherence to guideline-recommended diet and exercise control; willing and able to comply with lifestyle interventions throughout the study.
• On insulin therapy following adequate trials of standard and advanced glucose-lowering regimens as per guidelines.
• Subjects are dependent on insulin therapy.
• Women of childbearing potential, or male participants whose partners are of childbearing potential, must agree to use highly effective contraception throughout the study and for at least 6 months post-treatment.
• Able to understand the study protocol, willing to participate voluntarily, and provide signed written informed consent.

You may not qualify if:

• Diagnosis of any form of diabetes other than T2DM.
• Daily insulin dose \>1.5 U/kg or total daily dose \<20 U.
• Fasting plasma glucose ≥15.0 mmol/L.
• Positive for any diabetes-related autoantibodies at screening (prior to adipose tissue collection).
• Proliferative diabetic retinopathy requiring treatment or unstable.
• Active infection; hepatitis B, hepatitis C, syphilis, HIV antibody positivity; or history of tuberculosis.
• History of major cardiovascular or cerebrovascular disease.
• Uncontrolled hypertension despite pharmacological therapy.
• Clinically significant abnormal liver function tests.
• Clinically significant abnormal renal function tests.
• Clinically significant abnormalities in hematology parameters.
• Positive pregnancy test; breastfeeding.
• History of malignant tumor, except for malignancies with an excellent expected prognosis after curative treatment.
• History of tobacco dependence, alcohol abuse, substance abuse, or illicit drug use.
• Use of concomitant medications (other than current antidiabetic agents) that, in the Investigator's opinion, may interfere with glycemic control.

Sponsors & Collaborators

• Hangzhou Reprogenix Bioscience, Inc: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Linong Ji

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linlin Jiang

CONTACT

+86+571-88601920; linlin.jiang@reprogenix.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2032
• Last Updated: September 8, 2026

Record last verified: 2026-09

Locations

CN (1)