Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-27 @ 10:31 PM
Study NCT ID:
NCT05127135
Status:
UNKNOWN
Last Update Posted:
2021-11-19
First Post:
2021-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054218', 'term': 'Precursor T-Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}], 'ancestors': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-12-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-09', 'studyFirstSubmitDate': '2021-11-09', 'studyFirstSubmitQcDate': '2021-11-09', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression free survival time', 'timeFrame': '3 years', 'description': 'The interval between administration and disease progression or death.'}, {'measure': 'Overall survival time', 'timeFrame': '3 years', 'description': 'The interval between administration and death caused by any reason.'}, {'measure': 'Event-free survival', 'timeFrame': '3 years', 'description': 'EFS is calculated from administration to death, progression of the disease, relapse or gene recurrence, whichever comes first, or last visit.'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-related grade≥3Adverse Events or SAE', 'timeFrame': 'within 4 weeks after infusion', 'description': "Therapy-related adverse events or SAE will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)."}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '4 to 6 weeks after infusion', 'description': 'Description:\n\nFor T-ALL, Objective response rate(ORR) is the percentage of patients who achieve CR or CRi, determined by National Comprehensive Cancer Network (NCCN) clinical practice guidelines in oncology Acute Lymphoblastic Leukemia (2020.V1) ;\n\nFor lymphoma, ORR is the incidence of either a complete response (CR) or a partial response (PR). Response will be assessed using the 2014 Lugano criteria.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T-Acute Lymphoblastic Leukemia', 'T-cell Non-Hodgkin Lymphoma', 'T-cell Acute Lymphoblastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a single dose escalation study to evaluate the safety and clinical activity of ThisCART7(Allogeneic CAR-T targeting CD7) in patients with refractory or relapsed CD7 positive T cell malignancies.', 'detailedDescription': 'This is a single-center, nonrandomized, open-label, dose-escalation study to evaluate the safety and clinical activity of ThisCART7 in patients with refractory or relapsed CD7 positive T cell malignancies, such as T-cell Acute Lymphoblastic Leukemia, T-cell Acute Lymphoblastic Lymphoma and T-cell Non-Hodgkin Lymphoma. The dose range is 0.5-6 x 10\\^6 cells per kg body weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with relapsed and refractory CD7 + T cell hematologic malignancies (including, but not limited to, T-cell leukemia, extranodal NK/ T-cell lymphoma nasal, peripheral T-cell lymphoma, enteropathy associated T-cell lymphoma and anaplastic T-cell lymphoma, etc.);\n2. No alternative treatment options deemed by investigator;\n3. Measurable or detectble disease at time of enrollment;\n4. Age 18-70 years old, no gender and race limited;\n5. Eastern cooperative oncology group (ECOG) performance status of ≤2;\n6. Cardiac ejection fraction ≥ 40%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO);\n7. Estimated life expectancy \\> 12 weeks deemed by investigator;\n8. Serum creatinine ≤ 1.5 upper limit of normal (ULN);\n9. Serum ALT/ AST ≤ 5 upper limit of normal (ULN);\n10. Signed informed consent form (ICF).\n\nExclusion Criteria:\n\n1. Women in pregnancy or lactation;\n2. Uncontrolled infection;\n3. Active hepatitis B virus or hepatitis C virus infection;\n4. Concurrent use of corticosteroids or other immunosuppressant medications for chronic disease;\n5. Prior treatment with an allogeneic stem cell transplant within 100 days;\n6. Grade 2-4 Active graft versus host disease;\n7. History of HIV infection;\n8. With central nervous system involvement;\n9. Patients combine with other disease cause neutrophil count (ANC) \\< 750/uL or PLT\\< 50,000/uL.'}, 'identificationModule': {'nctId': 'NCT05127135', 'briefTitle': 'Safety and Efficacy of ThisCART7 in Patients With Refractory or Relapsed T Cell Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fundamenta Therapeutics, Ltd.'}, 'officialTitle': 'A Study to Evaluate the Safety and Clinical Activity of Allogeneic CAR-T Targeting CD7 in Patients With Refractory or Relapsed T Cell Malignancies', 'orgStudyIdInfo': {'id': 'ThisCART7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ThisCART7 cells injections', 'description': 'In this study, allogeneic anti-CD7 CAR T Cells(ThisCART7 cells) is used to treat patients with refractory or relapsed CD7 positive T cell malignancies.', 'interventionNames': ['Biological: ThisCART7 cells']}], 'interventions': [{'name': 'ThisCART7 cells', 'type': 'BIOLOGICAL', 'description': '0.5-6 x 10\\^6 CAR T cells per kg body weight', 'armGroupLabels': ['ThisCART7 cells injections']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingbing Wang', 'role': 'CONTACT', 'email': 'wangxingbing@ustc.edu.cn', 'phone': '+86-18056075256'}], 'facility': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital)', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Li', 'role': 'CONTACT', 'email': 'jli@ctigen.com', 'phone': '+8618662604088'}, {'name': 'Ling He', 'role': 'CONTACT', 'email': 'lhe@ctigen.com', 'phone': '+8618626100886'}], 'facility': 'Fundamenta Therapeutice Co.,Ltd', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Li Jun, Ph.D', 'role': 'CONTACT', 'email': 'jli@ctigen.com', 'phone': '+86-18662604088'}, {'name': 'He Ling', 'role': 'CONTACT', 'email': 'lhe@ctigen.com', 'phone': '+86-18626100886'}], 'overallOfficials': [{'name': 'Wang Xingbing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of USTC (Anhui Provincial Hospital)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundamenta Therapeutics, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of University of Science and Technology of China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}