Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-01-28 @ 3:33 AM
Study NCT ID:
NCT07142161
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': '1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with type 1 diabetes presenting with any of the following conditions:\n\nImpaired 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\n\n* Age ≤ 60 years\n* Body weight ≥ 40 kg\n* 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.\n* MMTT stimulated C-peptide peak \\> 0.1 nmol/L, or fasting C-peptide \\> 0.05 nmol/L\n* Female subjects of childbearing potential must have a negative serum or urine pregnancy test at screening\n* 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\n* The subject or their legal guardian voluntarily participates in this study and is able to sign the informed consent form\n\nExclusion Criteria:\n\n* If any of the following criteria are met, the subject will be excluded from the study.\n\nType 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)\n\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 x ULN, or total bilirubin ≥ 1.5 x ULN\n* Severe heart disease, with any of the following:\n* Myocardial infarction within 1 year before enrollment\n* Signs or symptoms of heart failure of NYHA Class ≥ 3 within 1 year before enrollment\n* Left ventricular ejection fraction (LVEF) \\< 50% at screening\n* 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)\n* Severe concurrent diabetic nephropathy, with an estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m2\n* Currently undergoing or expected to require renal replacement therapy during the study\n* 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\n* Participated in another clinical study within 3 months prior to enrollment\n* Received a live attenuated vaccine within 4 weeks prior to enrollment\n* The investigator considers the patient to have latent T1DM, including latent autoimmune diabetes in adults (LADA) and latent autoimmune diabetes in the young (LADY)\n* The investigator believes there are other reasons that make the subject unsuitable for this clinical study"}, 'identificationModule': {'nctId': 'NCT07142161', 'briefTitle': 'A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allo-CD7 CAR-T Cells in T1DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nanjing Bioheng Biotech Co., Ltd.'}, 'officialTitle': 'A Study on the Safety, Preliminary Efficacy, and Cellular Kinetics of Allogeneic CD7-targeted CAR-T Cell Injection in the Treatment of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'RD13-02T-AS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RD13-02', 'description': 'CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphami', 'interventionNames': ['Drug: RD13-02 cell infusion']}], 'interventions': [{'name': 'RD13-02 cell infusion', 'type': 'DRUG', 'description': 'CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphami', 'armGroupLabels': ['RD13-02']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'country': 'China', 'facility': 'Bioheng', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Bioheng Biotech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}