Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-03 @ 2:09 AM
Study NCT ID:
NCT03854994
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and 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': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.', 'timeFrame': '0 to 14 days post infusion', 'description': 'The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.'}, {'measure': 'Copies numbers of CAR in peripheral blood (PB)', 'timeFrame': '1 year post infusion', 'description': 'Copies numbers of CAR in peripheral blood (PB)'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years post infusion', 'description': 'For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason'}, {'measure': 'Duration of Response after administration', 'timeFrame': '2 years post infusion', 'description': 'Duration of Response after administration'}, {'measure': 'Progress Free Survival after administration', 'timeFrame': '2 years post infusion', 'description': 'Progress Free Survival after administration'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Cell Lymphoma', 'B-cell Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia （B-ALL）.', 'detailedDescription': 'The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;\n2. 18 Years and older, Male and female;\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;\n\nB-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:\n\n1. B-cell acute lymphoblastic leukemia;\n2. Indolent B-cell lymphomas;\n3. Aggressive B-cell lymphoma; 4、 Subjects:\n\n(1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.\n\n5、 Have measurable or evaluable tumor foci; 6、 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);\n2. Total bilirubin ≤34.2μmol/L;\n3. Serum creatinine\\<220μmol/L;\n4. Baseline oxygen saturation≥95%;\n5. Left ventricular ejection fraction（LVEF）≥40%. 7、 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); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、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': 'NCT03854994', 'briefTitle': 'CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and 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 With Synthetic Biology Optimizing Nano-vector T Cells Injection for Subjects With Relapsed/Refractory/High-risk B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': '201707202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-CD19 CAR-T Cells Injection', 'description': 'Dosage form：injection Dosage:1-5x10\\^6/kg, 70ml/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', 'otherNames': ['KD-019 CAR-T cells Injection'], 'description': 'Autologous genetically modified anti-CD19 CAR transduced T cells', 'armGroupLabels': ['Anti-CD19 CAR-T Cells Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lan Shi', 'role': 'CONTACT', 'email': 'shi_lanlan@yahoo.com', 'phone': '86-18988158897'}, {'name': 'Jiabao Song', 'role': 'CONTACT', 'email': 'jiabaosong668@gmail.com', 'phone': '86-15663656065'}], 'facility': "Kunming Yan'an Hospital, Oncology Department", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Peixian Zhang', 'role': 'CONTACT', 'email': 'px29@163.com', 'phone': '86-0871-63211268'}], 'overallOfficials': [{'name': 'Peixian Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': "Kunming Yan'an Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Yan'an Affiliated Hospital of Kunming Medical University", 'class': 'OTHER'}, 'collaborators': [{'name': 'KAEDI', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}