Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2026-01-01 @ 10:59 AM
Study NCT ID:
NCT06152757
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-07-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Limiting Toxicity (DLT)', 'timeFrame': 'From the infusion (Day 0) to Day 28', 'description': 'Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).'}, {'measure': 'Maximum tolerated dose', 'timeFrame': 'From the infusion (Day 0) to Day 28', 'description': 'The maximum CAR-T dose that can be tolerated in the study.'}, {'measure': 'AE, SAE, AESI, CRS, ICANS, TEAE', 'timeFrame': 'The day of leukapheresis to 12 months after infusion', 'description': 'The incidence of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), cytokine release syndrome (CRS) immune cell associated neurotoxicity syndrome (ICANS) and treatment-emergent adverse events (TEAE).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Tumors']}, 'descriptionModule': {'briefSummary': 'This study is an exploratory single-arm, open, modified "3+3" dose escalation study with BGT007H injection. Approximately 11 to 14 subjects with recurrent/refractory gastrointestinal tumors will be enrolled to evaluate the safety of BGT007H injection.\n\nFour dose levels were designed for this study: 1.0×10\\^8cells, 3.0×10\\^8cells, 1.0×10\\^9cells, and 3.0×10\\^9cells. The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic profile of BGT007H cell therapy in patients with recurrent/refractory digestive tract tumors, to determine the maximum tolerated dose or the best effective dose, and to initially evaluate the effectiveness of BGT007H cell products.', 'detailedDescription': 'Main research objectives:\n\nEvaluation of the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors\n\nSecondary research objectives:\n\n1. Evaluate the pharmacokinetic (PK) characteristics of BGT007H cells after reinfusion;\n2. Evaluation of the initial effectiveness of BGT007H cell therapy in patients with recurrent/refractory gastrointestinal tumors\n\nExploratory Purpose\n\n1. Exploring the correlation between the proliferation and survival of BGT007H cells in vivo and their therapeutic effects;\n2. Exploring the correlation between target expression levels and efficacy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Resources sign written informed consent;\n* 2, age ≥18, male and female can;\n* 3\\. Expected survival ≥3 months;\n* 4\\. The Eastern Cancer Collaboration (ECOG) physical status score was 0-1;\n* 5\\. Biopsy specimen or pathological wax section test (within 3 years before accepting the signed informed consent) : positive target test;\n* 6\\. According to RECISTv1.1 solid tumor evaluation criteria, there is at least one measurable lesion;\n* 7\\. Patients with advanced gastrointestinal tumors (esophageal cancer, gastric cancer, pancreatic cancer or colorectal cancer, etc.) who have been diagnosed by histology/cytology as having failed the standard of second-line or above treatment or are not suitable for/refuse to accept the standard treatment or cannot tolerate the standard treatment; The definition of intolerance: according to CTCAE V5.0, the occurrence of ≥Ⅳ hematological toxicity or ≥Ⅲ non-hematological toxicity or ≥Ⅱ damage to the heart, liver, kidney and other important organs during treatment; Treatment failure is defined as disease progression (PD) during treatment or recurrence after the end of treatment (including postoperative recurrence);\n* 8, can establish monopexy or venous blood collection venous access, and there are no other contraindications for blood cell separation;\n* 9, with adequate organ and bone marrow function;\n* 10\\. During the study period and for 6 months after the end of dosing, fertile subjects (both male and female) must use effective medical contraception. For female subjects of reproductive age, a pregnancy test should be performed within 72 hours before the first dose, and the result is negative.\n\nExclusion Criteria:\n\n* 1\\. Active central nervous system metastasis (except stable after treatment);\n* 2, HIV positive, HBsAg positive simultaneously detected HBV DNA copy number positive (quantitative detection ≥1000cps/ml), HCV antibody positive and HCV RNA positive;\n* 3, mental or mental illness can not cooperate with treatment and efficacy evaluation;\n* 4\\. Subjects with severe autoimmune diseases and long-term use of immunosuppressants;\n* 5\\. Active or uncontrollable infection requiring systemic treatment within 14 days prior to enrollment;\n* 6\\. Any unstable systemic disease (including but not limited to: Active infections (except local infections); Unstable angina pectoris Cerebral ischemia or cerebrovascular accident (within 6 months prior to screening) Myocardial infarction (within 6 months prior to screening) Congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥Ⅲ; Severe arrhythmias requiring medical treatment; Have heart disease that requires treatment or uncontrolled hypertension after treatment (blood pressure \\> 160mmHg/100mmHg);\n* 7, combined with lung, brain, kidney and other important organ dysfunction;\n* 8\\. The subject has undergone major surgery or severe trauma within 4 weeks prior to receiving cell therapy, or is expected to undergo major surgery during the study period;\n* 9\\. Received any systemic chemotherapy, immunotherapy or small molecule targeted therapy within 1-2 weeks or 5 half-lives (whichever is shorter) before anapheresis;\n* 10\\. The subject currently has or has had other malignant tumors that cannot be cured within 3 years, except cervical cancer or basal cell carcinoma of the skin, and other malignant tumors with a disease-free survival of more than 5 years;\n* 11, received chimeric antigen receptor modified T cells (including CAR-T, CTT-T) treatment within half a year;\n* 12\\. Combined graft-versus-host disease (GVHD)\n* 13\\. Subjects who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (except for inhalation or topical use); And subjects treated with systemic steroids within 72 hours prior to cell transfusion (except for inhalation or topical use);\n* 14\\. Severe allergy or history of allergy;\n* 15\\. Subjects requiring anticoagulation therapy;\n* 16, pregnant or breastfeeding women, or six months within the pregnancy plan (unisex;\n* 17\\. Researchers believe that there are other reasons for not being included in the treatment.'}, 'identificationModule': {'nctId': 'NCT06152757', 'briefTitle': 'BGT007H Cells for the Treatment of Recurrent/Refractory Gastrointestinal Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioSyngen Pte Ltd'}, 'officialTitle': 'Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Gastrointestinal Tumors', 'orgStudyIdInfo': {'id': 'BR-BGT-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BGT007H injection', 'description': 'Intravenous infusion', 'interventionNames': ['Biological: First dose', 'Biological: Second dose', 'Biological: The third dose', 'Biological: The fourth dose']}], 'interventions': [{'name': 'First dose', 'type': 'BIOLOGICAL', 'description': '1.0×10\\^8cells,Intravenous infusion，1 subject is planned to be enrolled', 'armGroupLabels': ['BGT007H injection']}, {'name': 'Second dose', 'type': 'BIOLOGICAL', 'description': '3.0×10\\^8cells,Intravenous infusion，3 subject is planned to be enrolled', 'armGroupLabels': ['BGT007H injection']}, {'name': 'The third dose', 'type': 'BIOLOGICAL', 'description': '1.0×10\\^9cells,Intravenous infusion，3 subject is planned to be enrolled', 'armGroupLabels': ['BGT007H injection']}, {'name': 'The fourth dose', 'type': 'BIOLOGICAL', 'description': '3.0×10\\^9cells,Intravenous infusion，3 subject is planned to be enrolled', 'armGroupLabels': ['BGT007H injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinfeng Chen', 'role': 'CONTACT', 'email': 'fengxinchen1985@163.com', 'phone': '0371-66295320'}, {'name': 'Dan Wang', 'role': 'CONTACT', 'email': 'dan.wang1002@163.com', 'phone': '13383812031'}], 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Xinfeng Chen', 'role': 'CONTACT', 'email': 'fengxinchen1985@163.com', 'phone': '0371-66295320'}, {'name': 'Dan Wang', 'role': 'CONTACT', 'email': 'wang.dan1002@163.com', 'phone': '13383812031'}], 'overallOfficials': [{'name': 'Yi Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Zhengzhou University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioSyngen Pte Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}