Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
Study NCT ID:
NCT03540303
Status:
UNKNOWN
Last Update Posted:
2018-05-30
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cytoplasmic Activated PD-1 CAR T Cells in Refractory/Relapsed B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': "CAR19 T cell therapy improves the clinical efficacy of refractory/relapsed B-cell lymphoma, and the combined PDL1 inhibitors may further improve the efficacy of CD19 CART in the treatment of lymphomas. The clinical efficacy of KITE's CAR19 T cells and PD-L1 inhibition was reported. This phase 1 study was conducted in 9 patients with DLBCL, 8 patients got remission and during which 5 got complete remission. However, this type of treatment requires more data and observation in a larger sample of patients. In addition, Kite Pharmaceuticals' CD19 CART is priced at 370,000 US dollars. The cost of immune checkpoint inhibitors is also very expensive. Only very small proportion of patients could afford for that expenses. In this study, genetically engineered CAR T cells, which carry cytoplasmic activated PD1, are not inhibited by PDL1 molecules, will avoid the simultaneous application of immune checkpoint antibodies and the according adverse events."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-29', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety: occurrence of study related adverse events', 'timeFrame': '6 months', 'description': 'occurrence of study related adverse events'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': '3 months and 6 months', 'description': 'tumor burdens shrink more than 30 percent by RECIST1.1'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['relapsed/refractory, B cell, lymphoma, CAR'], 'conditions': ['Relapsed Non Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and efficacy of CAR19 T cells carrying cytoplasmic activated PD1 in patients with refractory relapsed B-cell lymphoma', 'detailedDescription': 'Although CAR19 T cell therapy brings hope, the patients with refractory/relapsed B-cell lymphoma is still a problem for the current treatment. There are still some patients with poor therapeutic efficacy, and the efficacy of CAR19-T cell therapy remains to be improved. Basic research shows that there is a synergistic effect between CAR-T cell therapy and anti-PD1 pathway, and it did have efficacy in clinic. However, the regimen of CAR19-T cells combined anti-PD1 inhibitors need to be combined with the application of anti-PD1 antibody and culture of CART cells during the treatment, there may be adverse events to PD1 antibodies. In this study, CAR19T cells carrying cytosolic activated PD1 possess the dual effects of CAR19T cells and anti-PD1 or anti-PD-L1 antibodies while overcoming the adverse events of anti-PD1 inhibitors, and might have better efficacy than conventional CAR19T cells plus anti-PD1 or anti-PD-L1 antibody treatment, with fewer side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-70 years old and the expected lifetime \\>3 months\n* Refractory/relapsed CD19 positive B cell lymphoma by pathology\n* ECOG score \\<2\n* Measureable lesions according to RECIST 1.1\n* Sufficient heart, liver, kidney and bone marrow function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN; bone marrow: WBC ≥ 2.0 × 109/L, Hb ≥ 80 g/L, PLT ≥ 30 × 109/L)\n* no serious allergies\n* No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)\n* No other history of malignancy\n* No serious mental disorders\n* Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study\n* The patient himself agrees to participate in this clinical study and signed the "informed consent"\n\nExclusion Criteria:\n\n* Lactating women\n* Severe infectious or viral diseases (HIV positive, syphilis, etc.)\n* Active hepatitis B or C viral hepatitis\n* Patients who used high-dose glucocorticoids within 1 week\n* Participation in other clinical studies in the past 3 months or having been treated with other gene products'}, 'identificationModule': {'nctId': 'NCT03540303', 'briefTitle': 'Cytoplasmic Activated PD-1 CAR T Cells in Refractory/Relapsed B Cell Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Phase Ⅰ Study of CAR19 T Cells Carrying Cytoplasmic Activated PD-1 in the Treatment of Refractory/Relapsed B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'HenanCH CAR 2-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR19 T cells carrying cytoplasmic activated PD-1', 'description': 'patients with refractory/relapsed B-NHL receive a preconditioning before infusion of CAR T cells.', 'interventionNames': ['Drug: CAR19 T cells carrying cytoplasmic activated PD-1']}], 'interventions': [{'name': 'CAR19 T cells carrying cytoplasmic activated PD-1', 'type': 'DRUG', 'description': 'step 1: Collect 50-100ml of peripheral blood for culture of CAR19 T cells carrying cytoplasmic activated PD-1 step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 2x106 /kg for the first 3 patients, 6x106 /kg for the second 3 patients and 18x106 /kg for the third 3 patients.\n\nAfter finishing this, another 6 patients will be enrolled for observation of efficacy.', 'armGroupLabels': ['CAR19 T cells carrying cytoplasmic activated PD-1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quanli Gao, M.D', 'role': 'CONTACT', 'email': 'gaoquanli2015@126.com', 'phone': '+86-15038171966'}, {'name': 'Lu Han, M.D', 'role': 'CONTACT', 'email': 'luhan0377@163.com', 'phone': '+86-13838583031'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yongping Song, M.D', 'role': 'CONTACT', 'email': 'songyongping2018@126.com', 'phone': '+86-371-65587199'}, {'name': 'Quanli Gao, M.D', 'role': 'CONTACT', 'email': 'gaoquanli2015@126.com', 'phone': '+86-15038171966'}], 'overallOfficials': [{'name': 'Yongping Song, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Henan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Pregene (ShenZhen) Biotechnology Company, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}