Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT04916860
Status:
UNKNOWN
Last Update Posted:
2023-03-31
First Post:
2021-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2021-06-01', 'studyFirstSubmitQcDate': '2021-06-01', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, '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 CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity'}, {'measure': 'Remission Rate', 'timeFrame': '3 months post CAR-T cells infusion', 'description': 'To obsere the efficacy of CAR-T cells after infusion, complete remission (CR), complete remission with incomplete recovery of blood cells (CRi), minimal tumor residual positive(MRD+) or negative (MRD-) CR/CRi, disease recurrence or progression (PD) will be used for evaluation.'}], 'secondaryOutcomes': [{'measure': 'duration of response (DOR)', 'timeFrame': '24 months post CAR-T cells infusion', 'description': 'duration of response (DOR)'}, {'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': 'progression-free survival (PFS)', 'timeFrame': '24 months post CAR-T cells infusion', 'description': 'progression-free survival (PFS) time'}, {'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'}, {'measure': 'CAR-T proliferation', 'timeFrame': '3 months post CAR-T cells infusion', 'description': 'percentage of CD7 CAR- T cells measured by flow cytometry method'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SenL-T7 CAR T Cells for CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD7 CAR-T cell in the treatment of relapsed and refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma', 'detailedDescription': "This study is an open, prospective, dose-increasing clinical study with patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma as subjects. In order to evaluate the safety and efficacy of SENL-T7 in patients with CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma, the PK/PD indicators of SENL-T7 are also collected. In this study, no dose grouping is set, and 0.5-2E6 /kg× actual body weight dose is selected for reinfusion according to patients' disease diagnosis and tumor load.\n\nThe Main research objectives:\n\nTo evaluate the safety and efficacy of SENL-T7 in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma.\n\nThe Secondary research objectives:\n\nTo investigate the cellular dynamics of SENL-T7 CAR T cells in patients with relapsed or refractory CD7+ T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of relapsed/refractory T-cell lymphoblastic leukemia or T-cell lymphoblastic lymphoma: Induction therapy failed to achieve a complete remission of minor residual negative; Recurrence: after complete remission, any tumor load in the peripheral blood or bone marrow was 5%, or slightly residual positive, or new extramedullary lesions occurred；\n2. CD7 expression in tumor cells was detected by flow cytometry；\n3. Life expectancy greater than 12 weeks；\n4. KPS or Lansky score≥60;\n5. HGB≥70g/L (can be transfused);\n6. 2-70 years old;\n7. oxygen saturation of blood#90%#;\n8. Total bilirubin (TBil)≤3 × upper limit normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal;\n9. Informed consent explained to, understood by and signed by patient/ guardian.\n\nExclusion Criteria:\n\n1. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\\<30% or LVEF(left ventricular ejection fraction)\\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment);\n2. Has an active GvHD;\n3. Has a history of severe pulmonary function damaging;\n4. With other tumors which is/are in advanced malignant and has/have systemic metastasis;\n5. Severe or persistent infection that cannot be effectively controlled;\n6. Merging severe autoimmune diseases or immunodeficiency disease;\n7. Patients with active hepatitis B or hepatitis C(\\[HBVDNA+\\]or \\[HCVRNA\n\n +\\]);\n8. Patients with HIV infection or syphilis infection;\n9. Has a history of serious allergies on Biological products (including antibiotics);\n10. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BKvirus, or HHV(human herpesvirus)-6.\n11. Presence of symptomatic disorders of the central nervous system, which include but not limited to uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, and cerebellar disease, etc.;\n12. Have received transplant treatment for less than 6 months in prior to enrollment;\n13. Being pregnant and lactating or having pregnancy within 12 months;\n14. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.'}, 'identificationModule': {'nctId': 'NCT04916860', 'briefTitle': 'Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hebei Senlang Biotechnology Inc., Ltd.'}, 'officialTitle': 'Clinical Study of SenL-T7 CAR T Cells in the Treatment of Relapsed and Refractory CD7+ T-cell Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma', 'orgStudyIdInfo': {'id': 'SenL-T7 for CD7+leukemia/T-LBL'}}, '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': 'Beijingcun', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei yanda Ludaopei Hospital', 'geoPoint': {'lat': 41.26103, 'lon': 119.10946}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Senlang Biotechnology Inc., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}