Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT07181720
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D065646', 'term': 'Thyroid Carcinoma, Anaplastic'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D013945', 'term': 'Thymoma'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D013953', 'term': 'Thymus Neoplasms'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-28', 'studyFirstSubmitDate': '2025-09-12', 'studyFirstSubmitQcDate': '2025-09-12', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Objective response rate (ORR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]', 'timeFrame': '2 years', 'description': 'Objective response rate includes：The proportion of subjects who achieved CR, PR after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.'}, {'measure': 'Duration of Response (DOR) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]', 'timeFrame': '2 years', 'description': 'DOR will be assessed from the first assessment of CR/PR/SD to the first assessment of recurrence or progression of the disease or death from any cause'}, {'measure': 'Progress-free survival(PFS) of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]', 'timeFrame': '2 years', 'description': 'PFS will be assessed from the first CD70 CAR-T cell infusion to death from any cause or the first assessment of progression(Assessed based on RECIST criteria)'}, {'measure': 'Overall survival(OS)of CD70 CAR-T treatment in patients with CD70-positive advanced malignancies [Effectiveness]', 'timeFrame': '2 years', 'description': 'OS will be assessed from the first CD70 CAR-T cell infusion to death from any cause (Assessed by investigators based on IRECIST criteria)'}], 'primaryOutcomes': [{'measure': 'To evaluate the safety of CAR-T cell preparations in the treatment of CD70-positive advanced malignancies [Safety and Tolerability]', 'timeFrame': '1 month', 'description': 'Incidence of adverse events during the study, evaluated per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and American Society for Transplantation and Cellular Therapy (ASTCT) criteria'}, {'measure': 'Obtained the recommended dose and infusion regimen of CAR-T cells for the treatment of patients with CD70-positive advanced malignancies [Safety and Tolerability]', 'timeFrame': '1 month', 'description': 'Dose-limiting toxicity after CD70 CAR-T cell infusion'}], 'secondaryOutcomes': [{'measure': 'Assessing disease control rates of CAR-T cell preparations in CD70-positive advanced malignancies [Effectiveness]', 'timeFrame': '1 and 3 months', 'description': 'Disease control rate: The proportion of subjects who achieved CR, PR, SD after CAR-T infusion accounted for all treated subjects (Assessed based on RECIST criteria)，the minimum value is 0%，maximum value is 100%, and higher scores mean a better outcome.'}, {'measure': 'To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】', 'timeFrame': 'From infusion through Month 3', 'description': 'Cmax: maximum observed level of circulating CAR-T cells in peripheral blood after infusion'}, {'measure': 'To characterize the in-vivo cellular kinetics of CAR-T cells【pharmacokinetics】', 'timeFrame': 'From infusion through Month 3', 'description': 'To determine the time to maximum observed level of circulating CAR-T cells (Tmax)；To estimate AUC0-28d and AUC0-90d for circulating CAR-T cells'}, {'measure': 'To assess the inflammatory response following CAR-T cell infusion', 'timeFrame': 'From infusion through Month 3', 'description': 'Serum levels of inflammation-related markers and cytokines, including but not limited to C-reactive protein (CRP), interleukin-6 (IL-6), and ferritin'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Cell Carcinoma (RCC)', 'Lung Cancer', 'Anaplastic Thyroid Carcinomas', 'Ovarian Cancer', 'Cervical Cancer', 'Thymic Carcinoma']}, 'descriptionModule': {'briefSummary': 'This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CD70-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CD70-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CD70-positive advanced malignancies were obtained and the recommended dose and infusion schedule.', 'detailedDescription': 'According to the different infusion methods, patients will be assigned to three parallel subgroups: intravenous infusion, intrapleural infusion, and intraperitoneal infusion.\n\nWithin each subgroup, the study is conducted in two sequential parts:\n\n1. .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level;\n2. .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender;\n2. Histologically or cytologically confirmed advanced/metastatic solid tumors (tumors with positive CD70 expression, confirmed histopathological ly with IHC 3+ score);\n3. Failed or intolerant to standard second-line treatments (at least one of the following: tyrosine kinase inhibitors (TKIs), poly(ADP-ribose) polymerase inhibitors (PARPi), anti-angiogenic therapy; disease progression or inability to tolerate surgery, chemotherapy, radiotherapy, or targeted therapy);\n4. At least one measurable lesion per RECIST 1.1 criteria, with measurable lesions defined as:\n\n 1. Extranodal lesions with a long axis ≥10mm on CT scan;\n 2. Lymph node lesions with a short axis ≥15mm on CT scan;\n 3. CT slice thickness ≤5mm.\n5. ECOG performance status of 0-2 ;\n6. Expected survival ≥12 weeks;\n7. No history of severe psychiatric disorders;\n8. Adequate organ function as defined by the following:\n\n 1. Hematology: White blood cell count \\>2.0×10⁹/L, neutrophils \\>0.8×10⁹/L, lymphocytes \\>0.5×10⁹/L, platelets \\>50×10⁹/L, hemoglobin \\>90g/L;\n 2. Cardiac: Echocardiogram showing left ventricular ejection fraction (LVEF) ≥50%, and ECG with no significant abnormalities;\n 3. Renal: Serum creatinine ≤2.0×ULN;\n 4. Hepatic: ALT and AST ≤3.0×ULN (may be relaxed to ≤5.0×ULN in cases with liver tumor infiltration); total bilirubin ≤2.0×ULN (may be relaxed to ≤3.0×ULN in cases with Gilbert's syndrome or liver tumor infiltration);\n 5. Oxygen saturation ≥92% without supplemental oxygen;\n9. Ability to undergo single or venous blood collection, with no contraindications to cellular collection;\n10. Female subjects must agree to use reliable contraception (excluding fertility awareness methods) from the time of informed consent until 1 year after CAR-T cell infusion;\n11. Subject or authorized guardian agrees to participate in the trial and signs the informed consent form (ICF), indicating understanding of the trial's purpose and procedures and willingness to participate.\n\nExclusion Criteria:\n\n1. Prior treatment with anti-CD70 therapies;\n2. Active/symptomatic central nervous system (CNS) metastasis or meningeal metastasis: Subjects with treated brain metastases are eligible if treatment was completed ≥4 weeks prior to screening and there is no evidence of progression on imaging;\n3. Prior treatments within specified time frames:\n\n 1. Participation in other interventional clinical trials within 3 months before cell infusion (for unapproved drugs, the last dose must be ≥3 months prior; for approved drugs, ≥5 half-lives prior to cell infusion);\n 2. Received chemotherapy or targeted therapy within 2 weeks prior to blood collection or within 5 half-lives of the drug (whichever is shorter);\n 3. Received \\>10mg/day prednisone (or equivalent) within 2 weeks prior to blood collection, unless for adrenal replacement or inhaled/local steroids (except for active autoimmune disease);\n 4. Received live attenuated vaccines within 4 weeks prior to screening;\n4. Active infection requiring systemic treatment or uncontrolled infection within 1 week before screening;\n5. History of any other malignancy within the past 3 years, except for treated and stable non-melanoma skin cancer or malignancies treated with curative intent and no evidence of active disease for ≥3 years;\n6. Cardiovascular conditions:\n\n 1. NYHA Class III or IV heart failure;\n 2. Myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to screening;\n 3. Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration);\n 4. Severe non-ischemic cardiomyopathy;\n7. Active or uncontrolled autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, systemic vasculitis, etc.;\n8. Positive for HBsAg or HBcAb with elevated HBV DNA in peripheral blood; positive for HCV antibodies with detectable HCV RNA levels; positive for HIV antibodies; positive syphilis test;\n9. Toxicity from prior anti-tumor treatments has not resolved to baseline or ≤grade 1, except for alopecia or peripheral neuropathy;\n10. History of venous thromboembolism (e.g., pulmonary embolism) requiring ongoing anticoagulation treatment, or meeting one of the following criteria:\n\n 1. Severe bleeding (grade 3 or 4) lasting for ≥30 days;\n 2. Post-thrombotic sequelae (e.g., persistent dyspnea and hypoxia) due to venous thromboembolism;\n11. Pregnant or breastfeeding women;\n12. Other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the trial."}, 'identificationModule': {'nctId': 'NCT07181720', 'briefTitle': 'CD70-Targeted CAR-T Therapy in CD70-Positive Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chongqing Precision Biotech Co., Ltd'}, 'officialTitle': 'Clinical Study of CD70-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CD70-Positive Malignant Solid Tumors', 'orgStudyIdInfo': {'id': 'PBC095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous of CD70-targeted CAR-T', 'description': 'Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\\^5 cells/kg', 'interventionNames': ['Biological: CD70-targeted CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Intrapleural infusion of CD70-targeted CAR-T', 'description': 'Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\\^5 cells/kg', 'interventionNames': ['Biological: CD70-targeted CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Intraperitoneal infusion of CD70-targeted CAR-T', 'description': 'Infusion of CD70-targeted CAR-T cells by dose of 3-10x10\\^5 cells/kg', 'interventionNames': ['Biological: CD70-targeted CAR-T cells']}], 'interventions': [{'name': 'CD70-targeted CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.', 'armGroupLabels': ['Intravenous of CD70-targeted CAR-T']}, {'name': 'CD70-targeted CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.', 'armGroupLabels': ['Intrapleural infusion of CD70-targeted CAR-T']}, {'name': 'CD70-targeted CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Administration method: intraperitoneal infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.', 'armGroupLabels': ['Intraperitoneal infusion of CD70-targeted CAR-T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230031', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Donglai Lv, MD', 'role': 'CONTACT', 'email': 'lvxunhuan@163.com', 'phone': '13655600090'}, {'name': 'Donglai Lv, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The 901 Hospital of Joint Logistics Support Force of People Liberation Army', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Donglai Lv, MD', 'role': 'CONTACT', 'email': 'lvxunhuan@163.com', 'phone': '+8613655600090'}], 'overallOfficials': [{'name': 'Donglai Lv, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The 901 Hospital of Joint Logistics Support Force of People Liberation Army'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Precision Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}