Trials Sponsors Conditions Drugs Pricing

Conditions

T1DM - Type 1 Diabetes Mellitus

Keywords

T1DMAllogeneic CD7-Targeted CAR-T Cell

Outcome Measures

Primary Outcomes (2)

Safety: Incidence of dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) in participants with type 1 diabetes mellitus treated with RD13-02.
From the date of signing informed consent to 3 months after CAR-T cell infusion.
Change from baseline in 4-hour MMTT C-peptide AUC at Months 3, 6, and 12.
From baseline to Month 12.

Secondary Outcomes (11)

Change from baseline in peak C-peptide during a mixed-meal tolerance test (MMTT) at Months 3, 6, and 12.
From baseline to Month 12.
Change from baseline in blood glucose area under the curve (AUC) during a mixed-meal tolerance test (MMTT) at Months 3, 6, and 12.
From baseline to Month 12.
Change from baseline in mean daily dose of exogenous insulin at Months 1, 3, 6, 9, and 12.
From baseline to Month 12.
Change from baseline in glycated hemoglobin (HbA1c) at Months 3, 6, 9, and 12.
From baseline to Month 12.
Change from baseline in fasting blood glucose at Months 1, 3, 6, 9, and 12.
From baseline to Month 12.
+6 more secondary outcomes

Study Arms (1)

Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM

EXPERIMENTAL

Biological: Allogeneic CD7-Targeted CAR-T Cell Injection

Interventions

Allogeneic CD7-Targeted CAR-T Cell InjectionBiological

RD13-02 will be administered as a single intravenous infusion using a dose-escalation design. The starting dose is dose level 1 (DL1, 5×10\^7). If no dose-limiting toxicity (DLT) is observed within 28 days after infusion, dose escalation will proceed to dose level 2 (DL2, 1×10\^8). If a DLT is observed, the cohort will be expanded to 6 participants and subsequent dose decisions will follow the standard 3+3 design. The study will be terminated if 2 participants experience DLTs at DL1. If DL1 shows acceptable safety and strong biological activity, the DL2 cohort may be omitted and expansion may proceed at DL1. The planned enrollment is up to 9 participants.

Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age ≥18 years and ≤40 years.
Participants with stage 2 or stage 3 type 1 diabetes mellitus, according to the staging criteria for type 1 diabetes defined in the ADA 2024 Standards of Care in Diabetes.

Sponsors & Collaborators

Shanghai Zhongshan Hospital
Otherlead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, 201508, China

RECRUITING

Jingjing JIANG, MD, PhDCONTACT86-021-64041990 jiang.jingjing@zs-hospital.sh.cn

HUIJIE ZHANG, MD, PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Jingjing JIANG, MD, PhD

CONTACT

86-021-64041990 jiang.jingjing@zs-hospital.sh.cn

Study Design

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

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 14, 2026

Study Start

April 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 2027

Estimated

You may not qualify if:

Any type of diabetes other than type 1 diabetes, such as gestational diabetes, monogenic diabetes, diabetes caused by pancreatic injury, or other secondary forms of diabetes (for example, diabetes caused by Cushing syndrome, thyroid dysfunction, or acromegaly).
Hematologic abnormalities at screening, including hemoglobin \<100 g/L, white blood cell count \<3 × 10\^9/L, neutrophil count \<1.5 × 10\^9/L, or platelet count \<75 × 10\^9/L.
Liver injury at screening, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN.
Severe heart disease, such as angina pectoris, myocardial infarction, heart failure, or clinically significant arrhythmia.
kidney disease, including severe diabetic kidney disease, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m², current or expected receipt of renal replacement therapy.
Ongoing use of medications that, in the investigator's judgment, may cause significant and sustained changes in the course of type 1 diabetes or immune status.
Uncontrolled diabetic ketoacidosis.
Uncontrolled infection at screening, or any of the following at screening: positive hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBeAb) with peripheral blood HBV DNA above the upper limit of normal; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; positive Epstein-Barr virus-encoded RNA (EBER), or EBV viral load above the upper limit of normal.
Active autoimmune disease other than type 1 diabetes that requires systemic immunotherapy or is associated with organ dysfunction.
Pregnant or breastfeeding women; participants planning to conceive within 1 year; or participants of childbearing potential who are unwilling to use effective contraception during the study.
History of malignancy, except for cases considered by the investigator to be cured and at no risk of recurrence.
Participation in another clinical study within 3 months before enrollment.
Receipt of a live attenuated vaccine within 4 weeks before enrollment, or plan to receive a live attenuated vaccine during the study period.
Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (1)

Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (1)

Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations