A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM

Nanjing Bioheng Biotech

Status and phase

Active, not recruiting

Early Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: RD13-02 cell infusion

Study type

Interventional

Funder types

Industry

Identifiers

NCT07142161

RD13-02T-AS

Details and patient eligibility

About

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

Enrollment

3 estimated patients

Sex

All

Ages

1 to 60 years old

Volunteers

No Healthy Volunteers

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 mellitus from pregnancy, single-gene mutation, pancreatic injury, or other secondary causes (e.g., Cushing's syndrome, thyroid dysfunction, or acromegaly)

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, or total bilirubin ≥ 1.5 x ULN
Severe heart disease, with any of the following:
Myocardial infarction within 1 year before enrollment
Signs or symptoms of heart failure of NYHA Class ≥ 3 within 1 year before enrollment
Left ventricular ejection fraction (LVEF) < 50% at screening
QTcF > 450 msec (males) or > 470 msec (females), based on the QTcF value from a single ECG or the average of three repeated ECGs taken more than 3 minutes apart (QT interval corrected by Fridericia's formula)
Severe concurrent diabetic nephropathy, with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
Currently undergoing or expected to require renal replacement therapy during the study
At screening, a subject tests positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e-antigen (HBeAg); a subject tests positive for hepatitis B e-antibody (HBeAb) with a peripheral blood HBV DNA level above the upper limit of normal; a subject tests positive for hepatitis C virus (HCV) antibody; a subject tests positive for human immunodeficiency virus (HIV) antibody; a subject tests positive for syphilis antibody; a subject tests positive for EBER or has an EBV viral load greater than the upper limit of normal
Participated in another clinical study within 3 months prior to enrollment
Received a live attenuated vaccine within 4 weeks prior to enrollment
The investigator considers the patient to have latent T1DM, including latent autoimmune diabetes in adults (LADA) and latent autoimmune diabetes in the young (LADY)
The investigator believes there are other reasons that make the subject unsuitable for this clinical study