NCT07528105 Allogeneic Anti-CD7 CAR-T for Type 1 Diabetes
| NCT ID | NCT07528105 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | T1DM - Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2026-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07528105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying T1DM - Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07528105 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07528105 currently recruiting?
Yes, NCT07528105 is actively recruiting participants. Contact the research team at jiang.jingjing@zs-hospital.sh.cn for enrollment information.
Where is the NCT07528105 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07528105 clinical trial?
NCT07528105 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 9 participants.
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