A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM (NCT07142161) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM
China3 participantsStarted 2025-07-20
Plain-language summary
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RD13-02 in patients with aT1DM
Who can participate
Age range1 Year – 60 Years
SexALL
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Inclusion Criteria:
* Patients with type 1 diabetes presenting with any of the following conditions:
Impaired hypoglycemia awareness (lack of sufficient autonomic symptoms when plasma glucose is below 54 mg/dL \[3 mmol/L\]) or other clinically diagnosed neuropathy caused by type 1 diabetes, including but not limited to gastrointestinal autonomic neuropathy Metabolic instability: two or more previous severe hypoglycemic events that required assistance from others, or two or more hospitalizations for ketoacidosis in the past year
* Age ≤ 60 years
* Body weight ≥ 40 kg
* At least one positive islet autoantibody, including glutamic acid decarboxylase autoantibody (GADA), protein tyrosine phosphatase autoantibody (IA-2A), insulin autoantibody (IAA) (only applicable within 2 weeks of insulin treatment), zinc transporter 8 antibody (ZnT8), islet cell autoantibody (ICA), etc.
* MMTT stimulated C-peptide peak \> 0.1 nmol/L, or fasting C-peptide \> 0.05 nmol/L
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening
* Both male and female subjects must be willing to use contraception from the time of signing the informed consent form until 12 months after cell infusion
* The subject or their legal guardian voluntarily participates in this study and is able to sign the informed consent form
Exclusion Criteria:
* If any of the following criteria are met, the subject will be excluded from the study.
Type 2 diabetes, or diabetes mell…
What they're measuring
1
The incidence of dose-limiting toxicity (DLT) of RD13-02 in patients with type 1 diabetes, as well as the incidence of adverse events (AE), serious adverse events (SAE), and adverse events of special interest (AESI)