T1DM - Type 1 Diabetes MellitusEarly Phase 1NCT07528105
Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes
A Early Phase 1 study testing Allogeneic CD7-Targeted CAR-T Cell Injection in people with T1DM - Type 1 Diabetes Mellitus, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Type 1 diabetes mellitus (T1DM) is a T cell-mediated autoimmune disease characterized by autoimmune destruction of pancreatic beta cells, leading to absolute insulin deficiency and lifelong dependence on exogenous insulin. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- T1DM - Type 1 Diabetes Mellitus
- What is being tested?
- Allogeneic CD7-Targeted CAR-T Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Apr 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Positive for at least one islet autoantibody at screening, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), insulin autoantibody (IAA) (applicable only to participants who have received insulin therapy for no more than 2 weeks), zinc transporter 8 autoantibody (ZnT8A), or islet cell autoantibody (ICA). Participants positive for two or more autoantibodies will be prioritized for enrollment.
- Peak C-peptide >0.2 nmol/L during a mixed-meal tolerance test (MMTT), or fasting C-peptide >0.1 nmol/L.
- The participant or his/her legally authorized representative voluntarily agrees to participate in the study and is able to sign the informed consent form.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 201508
Jingjing JIANG, MD, PhD, 86-021-64041990, jiang.jingjing@zs-hospital.sh.cn
HUIJIE ZHANG, MD, PhD
About this study
Official title: A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-Targeted CAR-T Cell Injection for the Treatment of Type 1 Diabetes Mellitus
Type 1 diabetes mellitus (T1DM) is a T cell-mediated autoimmune disease characterized by autoimmune destruction of pancreatic beta cells, leading to absolute insulin deficiency and lifelong dependence on exogenous insulin. The disease results from loss of immune tolerance, with autoreactive T-cell responses against beta-cell antigens, and is typically associated with islet autoantibodies and insulitis. Although insulin therapy remains the standard of care, it does not correct the underlying autoimmune process.
Non-insulin therapeutic strategies for T1DM are mainly directed toward immunomodulation and beta-cell replacement or regeneration. Among immunomodulatory approaches, previous studies have primarily focused on regulation of effector T cells and B cells. Novel immune-based therapies are needed to explore whether modulation of pathogenic immune cell populations may alter disease activity and preserve residual beta-cell function.
The purpose of this study is to evaluate the safety, preliminary efficacy, and cellular kinetics of an allogeneic CD7-targeted CAR-T cell injection in participants with early stage T1DM. Participants will receive the investigational product and undergo regular assessments of safety, tolerability, treatment-emergent adverse events, cellular kinetics, glycemic parameters, exogenous insulin requirement, beta-cell function, and immunologic biomarkers. This study is expected to generate preliminary clinical evidence regarding the feasibility and potential therapeutic effects of CD7-targeted CAR-T cell therapy in T1DM.
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Being tested
- Allogeneic CD7-Targeted CAR-T Cell Injection
- Keywords
- T1DM, Allogeneic CD7-Targeted CAR-T Cell
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM | Experimental | Not described Receives: Biological: Allogeneic CD7-Targeted CAR-T Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to Month 12.
Change from baseline in mean daily dose of exogenous insulin at Months 1, 3, 6, 9, and 12.
Measured: From baseline to Month 12.
Change from baseline in glycated hemoglobin (HbA1c) at Months 3, 6, 9, and 12.
Measured: From baseline to Month 12.
Change from baseline in fasting blood glucose at Months 1, 3, 6, 9, and 12.
Measured: From baseline to Month 12.
Change from baseline in time in range (TIR, %) on continuous glucose monitoring (CGM), defined as the percentage of time with glucose levels between 70-180 mg/dL (3.9-10.0 mmol/L), at Months 3, 6, and 12.
Measured: From baseline to Month 12.
Proportion of participants with HbA1c ≤7.0% and a reduction of ≥50% in insulin dose at Month 12.
Measured: Month 12.
Proportion of participants with MMTT C-peptide AUC >0.2 nmol/L at Month 12.
Measured: Month 12.
Incidence of clinically significant hypoglycemic events during the study period.
Measured: From baseline to Month 12.
Incidence of diabetic ketoacidosis (DKA) events.
Measured: From baseline to Month 12.
Expansion and persistence of RD13-02 in participants with type 1 diabetes mellitus.
Measured: From infusion through Month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DM - Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528105
- Sponsor's protocol ID
- B2026-141R
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-Targeted CAR-T Cell Injection for the Treatment of Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07528105
- Acronym / sponsor ID
- B2026-141R
- Conditions
- T1DM - Type 1 Diabetes Mellitus
- Keywords
- T1DM, Allogeneic CD7-Targeted CAR-T Cell
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 1 diabetes mellitus (T1DM) is a T cell-mediated autoimmune disease characterized by autoimmune destruction of pancreatic beta cells, leading to absolute insulin deficiency and lifelong dependence on exogenous insulin. The disease results from loss of immune tolerance, with autoreactive T-cell responses against beta-cell antigens, and is typically associated with islet autoantibodies and insulitis. Although insulin therapy remains the standard of care, it does not correct the underlying autoimmune process.
Non-insulin therapeutic strategies for T1DM are mainly directed toward immunomodulation and beta-cell replacement or regeneration. Among immunomodulatory approaches, previous studies have primarily focused on regulation of effector T cells and B cells. Novel immune-based therapies are needed to explore whether modulation of pathogenic immune cell populations may alter disease activity and preserve residual beta-cell function.
The purpose of this study is to evaluate the safety, preliminary efficacy, and cellular kinetics of an allogeneic CD7-targeted CAR-T cell injection in participants with early stage T1DM. Participants will receive the investigational product and undergo regular assessments of safety, tolerability, treatment-emergent adverse events, cellular kinetics, glycemic parameters, exogenous insulin requirement, beta-cell function, and immunologic biomarkers. This study is expected to generate preliminary clinical evidence regarding the feasibility and potential therapeutic effects of CD7-targeted CAR-T cell therapy in T1DM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM | Experimental | Biological: Allogeneic CD7-Targeted CAR-T Cell Injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Positive for at least one islet autoantibody at screening, including glutamic acid decarboxylase autoantibody (GADA), insulinoma-associated protein 2 autoantibody (IA-2A), insulin autoantibody (IAA) (applicable only to participants who have received insulin therapy for no more than 2 weeks), zinc transporter 8 autoantibody (ZnT8A), or islet cell autoantibody (ICA). Participants positive for two or more autoantibodies will be prioritized for enrollment.
- Peak C-peptide >0.2 nmol/L during a mixed-meal tolerance test (MMTT), or fasting C-peptide >0.1 nmol/L.
- The participant or his/her legally authorized representative voluntarily agrees to participate in the study and is able to sign the informed consent form.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic CD7-Targeted CAR-T Cell InjectionRD13-02 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. | Biological | Allogeneic CD7-Targeted CAR-T Cell (RD13-02) Injection for the Treatment of T1DM |
Primary outcome
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.
Time frame: 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.
Time frame: From baseline to Month 12.
11 secondary outcomes
Change from baseline in peak C-peptide during a mixed-meal tolerance test (MMTT) at Months 3, 6, and 12.
Time frame: 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.
Time frame: From baseline to Month 12.
Change from baseline in mean daily dose of exogenous insulin at Months 1, 3, 6, 9, and 12.
Time frame: From baseline to Month 12.
Change from baseline in glycated hemoglobin (HbA1c) at Months 3, 6, 9, and 12.
Time frame: From baseline to Month 12.
Change from baseline in fasting blood glucose at Months 1, 3, 6, 9, and 12.
Time frame: From baseline to Month 12.
Change from baseline in time in range (TIR, %) on continuous glucose monitoring (CGM), defined as the percentage of time with glucose levels between 70-180 mg/dL (3.9-10.0 mmol/L), at Months 3, 6, and 12.
Time frame: From baseline to Month 12.
Proportion of participants with HbA1c ≤7.0% and a reduction of ≥50% in insulin dose at Month 12.
Time frame: Month 12.
Proportion of participants with MMTT C-peptide AUC >0.2 nmol/L at Month 12.
Time frame: Month 12.
Incidence of clinically significant hypoglycemic events during the study period.
Time frame: From baseline to Month 12.
Incidence of diabetic ketoacidosis (DKA) events.
Time frame: From baseline to Month 12.
Expansion and persistence of RD13-02 in participants with type 1 diabetes mellitus.
Time frame: From infusion through Month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allogeneic CD7-Targeted CAR-T Cell Injection in people with T1DM - Type 1 Diabetes Mellitus, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingjing JIANG, MD, PhD (86-021-64041990, jiang.jingjing@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From the date of signing informed consent to 3 months after CAR-T cell infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.