Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04289220
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2020-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], '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'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], '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': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-12', 'studyFirstSubmitDate': '2020-02-26', 'studyFirstSubmitQcDate': '2020-02-26', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade and number of cytokine release syndrome and neurotoxic effects in participants receiving treatment', 'timeFrame': '14 day', 'description': 'Anti-CD19 CAR-T cells growing use requires further education/training and prompt management of safety and tolerability.'}, {'measure': 'Persistence of anti-CD19 CAR-T cells in participants', 'timeFrame': '1 year', 'description': 'Copies numbers of CAR in peripheral blood (PB)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason'}, {'measure': 'Progress Free Survival', 'timeFrame': '3 years', 'description': 'Progression-free survival refers to the period between the start of treatment for participants and the observation of disease progression or death for any reason.'}, {'measure': 'Duration of Response after administration', 'timeFrame': '3 years', 'description': 'Duration of Response after administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Cell Lymphoma', 'B-cell Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.', 'detailedDescription': 'Using piggyBac transposon/transposase system to deliver genes into primary human T cells - example expression of CD19 CAR.CARs specific to the human CD19 antigen were used. All CARs contained the scFv against human CD19 (clone FMC-63), The third BBz CD28z CAR consisted of the scFv linked to the intracellular domains of CD28, 4-1BB and CD3z through a CD28 transmembrane domain;\n\nSubjects with relapsed/refractory CD19-positive B-cell Lymphoma or B-ALL can participate if all eligibility criteria are met. All patients received chemotherapy with fludarabine and cyclophosphamide before the infusion of anti-CD19 CAR-T cells.. After the infusion, subjects will accept follow-up for side effects and effect of anti-CD19 CAR-T cells.\n\nFollow-up :\n\nSafety and adverse events (safety and tolerability of anti-CD19 CAR-T cell therapy within 14 days): The number and severity of adverse events, an evaluation of their association with the anti-CD19 CAR-T cell treatment, and the outcome of the adverse events. Possible adverse events include cytokine release syndrome, hypotension, reversible neurotoxicity, hypogammaglobulinemia, etc. CT was used to evaluate B-lymphoma lesions. B-ALL bone marrow samples were collected by bone marrow aspiration to assess minimal residual disease. Flow cytometry was used to detect proportion of T cells, B cells, and NK cells in the blood, and expression of CD3, CD4, CD8, anti-CD19 CAR to determine the effect of anti-CD19 CAR-T treatment. Plasma levels of the cytokines IFN-gamma, TNF-α, IL-2, GM-CSF, IL-10, and IL-6 were also determined.\n\nData analysis:\n\nOverall survival and progress free survival were determined by the Kaplan-Meier method, using all enrolled patients to determine overall survival.\n\nStudy procedures may be performed while hospitalized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;\n2. Male or female patients aged 18 to 70 years (inclusive);\n3. Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;\n4. B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:1) B-cell acute lymphoblastic leukemia;2) Indolent B-cell lymphomas;3) Aggressive B-cell lymphoma; 4) Multiple myeloma;\n5. Subjects:\n\n(1) Residual lesions remain after treatment and Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (2) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (3) Patients with high risk factors; (4) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.\n\n6\\. Have measurable or evaluable tumor foci;\n\n7\\. Liver, kidney and cardiopulmonary functions meet the following requirements:\n\n1\\) Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \\<3 ×upper limit of normal (ULN);2) Total bilirubin ≤34.2μmol/L;3) Serum creatinine\\<220μmol/L;4) Baseline oxygen saturation≥95%;5) Left ventricular ejection fraction（LVEF）≥40%.\n\n8\\. Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss);\n\n9\\. Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip;\n\n10\\. Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months;\n\nExclusion Criteria:\n\n1. Pregnant (urine/blood pregnancy test positive) or lactating women;\n2. Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;\n3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;\n4. Active or uncontrollable infection within four weeks prior to enrollment;\n5. Patients with active hepatitis B/C;\n6. HIV-infected patients;\n7. Severe autoimmune or immunodeficiency disorders;\n8. Patients are allergic to macromolecule drugs such as antigens or cytokines;\n9. Subjects participated in other clinical trials within 6 weeks before enrollment;\n10. Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);\n11. Mental illness;\n12. Drug abuse/addiction;\n13. The investigators consider other conditions unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT04289220', 'briefTitle': 'Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Yan'an Affiliated Hospital of Kunming Medical University"}, 'officialTitle': 'A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor in PiggyBac Transposon-Engineered T Cells for the Treatment of Patients With Relapsed/Refractory/High-risk B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': '2019-1-N-25318000002027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-CD19 CAR-T Cells Injection', 'description': 'Anti-CD19 CAR-T Cells Injection, Dosage form：injection Dosage:1-2.5x10\\^6/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time', 'interventionNames': ['Biological: Anti-CD19 CAR-T Cells Injection']}], 'interventions': [{'name': 'Anti-CD19 CAR-T Cells Injection', 'type': 'BIOLOGICAL', 'description': 'Dosage form：injection Dosage:1-2.5x10\\^6 cells/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time', 'armGroupLabels': ['Anti-CD19 CAR-T Cells Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lin Li', 'role': 'CONTACT', 'email': 'aileenali@163.com'}], 'facility': "Kunming Yan'an Hospital", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Zongliu Hou', 'role': 'CONTACT', 'email': 'hzl579@163.com', 'phone': '86-0871-63211157'}], 'overallOfficials': [{'name': 'Zongliu Hou', 'role': 'STUDY_DIRECTOR', 'affiliation': "Kunming Yan'an Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Yan'an Affiliated Hospital of Kunming Medical University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}