Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-24 @ 1:25 PM
Study NCT ID:
NCT04928105
Status:
UNKNOWN
Last Update Posted:
2022-05-31
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-24', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: Incidence and severity of adverse events', 'timeFrame': 'First 1 month post CAR-T cells infusion', 'description': 'To evaluate the possible adverse events occurred within first one month after CD7'}, {'measure': 'Remission Rate', 'timeFrame': '3 months post CAR-T cells infusion', 'description': 'Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)'}, {'measure': 'duration of response (DOR)', 'timeFrame': '24 months post CAR-T cells infusion', 'description': 'duration of response (DOR)'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': '24 months post CAR-T cells infusion', 'description': 'progression-free survival (PFS) time'}, {'measure': 'CAR-T proliferation', 'timeFrame': '3 months post CAR-T cells infusion', 'description': 'the copy number of CD7 CAR- T cells in the genomes of PBMC by qPCR method'}, {'measure': 'CAR-T proliferation', 'timeFrame': '3 months post CAR-T cells infusion', 'description': 'percentage of CD7 CAR- T cells measured by flow cytometry method'}, {'measure': 'Cytokine release', 'timeFrame': 'First 1 month post CAR-T cells infusion', 'description': 'Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, T-Cell']}, 'descriptionModule': {'briefSummary': 'This study is an open and prospective clinical study, taking patients with relapsed or refractory CD7+ lymphoma as the test subjects, in order to evaluate the safety and efficacy of Senl-T7 CAR-T for patients with CD7+ lymphoma.', 'detailedDescription': 'Main research purposes:\n\nTo evaluate the safety and efficacy of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma\n\nSecondary research purpose:\n\nTo investigate the cytokinetic characteristics of Senl-T7 CAR-T for relapsed or refractory CD7+ lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Diagnosed as relapsed or refractory lymphoma; 2. Tumor cells express CD7 (express CD7 by flow cytometry or immunohistochemistry); 3. The expected survival period is greater than 12 weeks; 4. KPS or Lansky score ≥60; 11 5. Age 2-70 years old; 6. HGB≥70g/L (can be transfused); 7. Indoor blood oxygen saturation\\> 90%; 8. Total bilirubin does not exceed 3 times the upper limit of normal value, and AST and ALT do not exceed 5 times the upper limit of normal value; 9. The subject or guardian understands and signs the informed consent form;\n\nExclusion Criteria:\n\n* 1\\. One of the following cardiac criteria: atrial fibrillation; myocardial infarction within the past 12 months; prolonged QT synthesis Syndrome or secondary QT prolongation is at the discretion of the investigator. Echocardiography LVSF\\<30% or LVEF\\< 50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (the absence of this symptom confirmed by echocardiography within 12 months after treatment); 2. There is active GVHD; 3. Have a history of severe pulmonary dysfunction diseases; 4. Merge other malignant tumors in advanced stage; 5. Combined with severe infection or persistent infection and cannot be effectively controlled; 6. Combined with severe autoimmune disease or congenital immunodeficiency; 7. Active hepatitis (hepatitis B virus deoxyribonucleic acid \\[HBVDNA\\] or hepatitis C virus ribonucleic acid \\[HCVRNA\\] test positive); 8. Human immunodeficiency virus (HIV) infection or syphilis infection or HTLV infection; 9. There is a history of severe allergies to biological products (including antibiotics); 10. Clinically significant viral infection, or uncontrollable viral reactivation, including EBV (Epstein-Barr virus), CMV (cytomegalovirus), ADV (adenovirus), BKV, HHV(human herpesvirus)-6; 11. There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, Cerebellar diseases, etc.; 12. Female patients are pregnant and lactating, or have a pregnancy plan within 12 months; 13. Circumstances that the researcher believes may increase the risk of the subject or interfere with the results of the test.'}, 'identificationModule': {'nctId': 'NCT04928105', 'briefTitle': 'Senl-T7 CAR-T Cells for Treatment of Relapsed or Refractory CD7+ Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hebei Senlang Biotechnology Inc., Ltd.'}, 'officialTitle': 'Clinical Study of Senl-T7 CAR-T Cells in the Treatment of Relapsed or Refractory CD7+ Lymphoma', 'orgStudyIdInfo': {'id': 'Senl-T7 CART for CD7+ lymphoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD7 CAR-T', 'interventionNames': ['Biological: Senl-T7']}], 'interventions': [{'name': 'Senl-T7', 'type': 'BIOLOGICAL', 'description': 'Patients will be treated with CD7 CAR-T cells', 'armGroupLabels': ['CD7 CAR-T']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yanda', 'state': 'Hebei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Peihua MD Lu, PhD', 'role': 'CONTACT', 'email': 'peihua_lu@126.com', 'phone': '008618611636172'}], 'facility': 'Hebei yanda Ludaopei Hospital'}], 'centralContacts': [{'name': 'Peihua MD Lu, PhD', 'role': 'CONTACT', 'email': 'peihua_lu@126.com', 'phone': '008618611636172'}, {'name': 'Jianqiang MD Li, PhD', 'role': 'CONTACT', 'email': 'limmune@gmail.com', 'phone': '008615511369555'}], 'overallOfficials': [{'name': 'Peihua MD Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Yanda Ludaopei Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Senlang Biotechnology Inc., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}