Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-07-19 @ 7:26 AM
Study NCT ID:
NCT02892695
Status:
UNKNOWN
Last Update Posted:
2016-12-06
First Post:
2016-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D054403', 'term': 'Leukemia, Prolymphocytic, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'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': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012680', 'term': 'Sensitivity and Specificity'}, {'id': 'D018941', 'term': 'Antigens, CD19'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D015703', 'term': 'Antigens, CD'}, {'id': 'D000943', 'term': 'Antigens, Differentiation'}, {'id': 'D000954', 'term': 'Antigens, Surface'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D000944', 'term': 'Antigens, Differentiation, B-Lymphocyte'}, {'id': 'D015778', 'term': 'Minor Histocompatibility Antigens'}, {'id': 'D006649', 'term': 'Histocompatibility Antigens'}, {'id': 'D007519', 'term': 'Isoantigens'}, {'id': 'D015415', 'term': 'Biomarkers'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-04', 'studyFirstSubmitDate': '2016-09-02', 'studyFirstSubmitQcDate': '2016-09-02', 'lastUpdatePostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events attributed to the administration of the anti-CD19 CAR-NK cells', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'Safety follow-up is 100 days from last CAR-NK infusion'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Lymphocytic Leukemia', 'Chronic Lymphocytic Leukemia', 'Follicular Lymphoma', 'Mantle Cell Lymphoma', 'B-cell Prolymphocytic Leukemia', 'Diffuse Large Cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34515338', 'type': 'DERIVED', 'citation': 'Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.'}, {'pmid': '28054442', 'type': 'DERIVED', 'citation': 'Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant.', 'detailedDescription': 'The purpose of this study is to evaluate the safety and optimal dose of PCAR-119 in patients who are going to receive stem cell transplantation but without available treatment to achieve complete remission prior to the transplant. In addition, some patients who enroll to other CD19-CAR-T cell therapy trials might be eligible for this trial if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale and female subjects with CD19+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to \\< 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD19-CAR-T cell therapy trials may be eligible if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:\n\n1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.\n2. Patients 3 years of age or older, and must have a life expectancy \\> 12 weeks.\n3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.\n4. Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR NK cells.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \\< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.\n6. Ability to give informed consent.\n\nExclusion Criteria:\n\n1. Pregnant or nursing women may not participate.\n2. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.\n3. Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.\n4. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.\n5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n6. The existence of unstable or active ulcers or gastrointestinal bleeding.\n7. Patients need anticoagulant therapy (such as warfarin or heparin).\n8. Patients need long-term antiplatelet therapy (aspirin at a dose \\> 300mg/d; clopidogrel at a dose \\> 75mg/d).\n9. Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.'}, 'identificationModule': {'nctId': 'NCT02892695', 'briefTitle': 'PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'PersonGen BioTherapeutics (Suzhou) Co., Ltd.'}, 'officialTitle': 'PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma', 'orgStudyIdInfo': {'id': 'PG-119-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-NK Cell immunotherapy', 'description': 'Enrolled patients will receive CAR-NK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.', 'interventionNames': ['Biological: anti-CD19 CAR-NK cells']}], 'interventions': [{'name': 'anti-CD19 CAR-NK cells', 'type': 'BIOLOGICAL', 'otherNames': ['chimeric antigen receptor NK cells with specificity for CD19'], 'description': 'The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19.', 'armGroupLabels': ['CAR-NK Cell immunotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215123', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Yang, Ph.D.', 'role': 'CONTACT', 'email': 'info@persongen.com', 'phone': '86-512-65922190'}, {'name': 'Yangyi Bao, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Xiang Sun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lin Yang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'PersonGen BioTherapeutics (Suzhou) Co., Ltd.', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Lin Yang, Ph.D.', 'role': 'CONTACT', 'email': 'lin.yang@persongen.com', 'phone': '86-512-65922190'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PersonGen BioTherapeutics (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "The First People's Hospital of Hefei", 'class': 'OTHER'}, {'name': 'Hefei Binhu Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}