Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04842812
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2021-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090204', 'term': 'Mesothelin'}, {'id': 'C110843', 'term': 'PSCA protein, human'}], 'ancestors': [{'id': 'D058851', 'term': 'GPI-Linked Proteins'}, {'id': 'D008562', 'term': 'Membrane Glycoproteins'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D058635', 'term': 'Lipid-Linked Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'TILs treatment of solid cancers'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2035-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2021-04-04', 'studyFirstSubmitQcDate': '2021-04-09', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of TILs/CAR-TILs treatment in advanced solid cancers', 'timeFrame': 'up to 36 months', 'description': 'Assessing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.'}], 'secondaryOutcomes': [{'measure': 'Primary clinical efficacy of the TILs/CAR-TILs treatment in advanced solid cancers', 'timeFrame': '15 years', 'description': 'Assessing various clinical response rates including complete response, partial response, stable disease, and progress disease during and after TILs/CAR-TILs treatment in advanced solid cancers.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver Cancer', 'Lung Cancer', 'Solid Tumor', 'TIL', 'CAR-TIL', 'PD1', 'CTLA4', 'GPC3', 'Mesothelin', 'B7-H3', 'CRISPRA-CAS9'], 'conditions': ['Liver Cancer', 'Lung Cancer', 'Breast Cancer', 'Colo-rectal Cancer', 'Brain Tumor', 'Solid Tumor, Adult', 'PD1', 'CTLA4']}, 'descriptionModule': {'briefSummary': 'Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.', 'detailedDescription': '1. Choose appropriate patients with advanced lung or other cancers, with written consent for this study;\n2. Perform biopsy or collect cancerous effusion in thorax or abdomen to obtain TILs by standard protocol;\n3. Grow TILs and engineered the tumor-effective TILs with CRISPRA-CAS9 technique to knockdown PD1 and electronic-transfection strategy to express scFvs that target PD1 and CTLA4; amplify the engineered T cells as needed, test the quality and killing activity of the TILs and then transfuse them back the patients via systemic or local injections via standard protocol, and follow up closely to collect related parameters as needed;\n4. To enhance the killing capability, tumor-noneffective TILs have also been genetically engineered to express various CARs targeting HER2/Mesothelin/Lewis-Y/PSCA/MUC1/ GPC3/AXL/EGFR/Claudin18.2/B7-H3/ROR1/GD2/AXL/Claudin6-DAP10 with knockdown of PD1/HPK1 as appropriate;\n5. Evaluate the clinical results as needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with advanced cancers that failed to current available therapies;\n2. Life expectancy \\>12 weeks;\n3. Adequate heart, lung, liver, kidney functions;\n4. Available for tumor biopsy or cancerous effusions;\n5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity;\n3. Active infectious disease related to bacteria, virus, fungi, et al;\n4. Other severe diseases that the investigators consider not appropriate;\n5. Pregnant or lactating women;\n6. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);\n7. Other conditions that the investigators consider not appropriate.'}, 'identificationModule': {'nctId': 'NCT04842812', 'briefTitle': 'Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'ZZTIL-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TILs/CAR-TILs treatment', 'description': 'Obtain TILs/CAR-TILs from advanced solid tumor patients and infuse them back to evaluate safety and clinical efficacy of the treatment.', 'interventionNames': ['Biological: TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3']}], 'interventions': [{'name': 'TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3', 'type': 'BIOLOGICAL', 'description': 'TILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.', 'armGroupLabels': ['TILs/CAR-TILs treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+862039195966'}, {'name': 'Bingjia He', 'role': 'CONTACT', 'email': '464677938@qq.com', 'phone': '+862039195965'}, {'name': 'Zhenfeng Zhang, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+862039195966'}, {'name': 'Bingjia He, MD', 'role': 'CONTACT', 'email': '464677938@qq.com', 'phone': '+862039195965'}], 'overallOfficials': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Guangzhou Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guangdong Zhaotai InVivo Biomedicine Co. Ltd.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}