Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-01-06 @ 4:57 AM
Study NCT ID:
NCT03398967
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], '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': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '24 weeks'}, {'measure': 'MTD of universal dual specificity CD19 and CD20 or CD22 CAR-T cells', 'timeFrame': '4 weeks', 'description': "The highest dose of universal dual specificity CD19 and CD20 or CD22 CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of universal dual s"}, {'measure': 'Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Six-month Objective response rate of complete remission and partial remission', 'timeFrame': '24 weeks'}, {'measure': 'Six-month Overall survival', 'timeFrame': '24 weeks'}, {'measure': 'Six-month Progression free survival', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B Cell Leukemia', 'B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory B-cell malignancies; however, a subset of patients relapse due to the loss of CD19 in tumor cells. Dual Specificity CD19 and CD20 or CD22 CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 or CD22. This is a phase 1/2 study designed to determine the safety of the allogenic gene-edited dual specificity CD19 and CD20 or CD22 CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory hematological malignancies.', 'detailedDescription': '1. PRIMARY OBJECTIVES:\n\n 1. To evaluate the feasibility and safety of universal dual specificity CD19 and CD20 or CD22 CAR-T cells in patients with relapsed or refractory leukemia and lymphoma.\n 2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells. Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD19 and CD20 or CD22 CAR-T cells over time.\n2. SECONDARY OBJECTIVES:\n\n 1. For patients with detectable disease, measure anti-tumor response due to universal dual specificity CD19 and CD20 or CD22 CAR-T cell infusions.\n 2. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and assess correlation with loss of detectable universal dual specificity CD19 and CD20 or CD22 CAR-T cells (loss of engraftment).\n\nThe CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using a "split dose" approach to dosing: 10% on day 0, 30% on day 1 and 60% on day 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female participant\n2. 12 Years to 70 Years (Child, Adult, Senior)\n3. Patient with relapsed or refractory B-cell leukemia or lymphoma\n4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n6. Adequate organ function\n\nExclusion Criteria:\n\n1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis\n3. Richter's syndrome\n4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening\n5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy\n6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible\n7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening\n8. Patient has an investigational medicinal product within the last 30 days prior to screening\n9. Previous treatment with investigational gene or cell therapy medicine products\n10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary\n11. Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT03398967', 'briefTitle': 'A Feasibility and Safety Study of Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cell Immunotherapy for Relapsed or Refractory Leukemia and Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Leukemia and Lymphoma With Universal CRISPR-Cas9 Gene-Editing CAR-T Cells Targeting CD19 and CD20 or CD22', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-026'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells', 'type': 'BIOLOGICAL', 'description': '1. Biological: Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells\n2. Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose. D2: 60% of total dose if patient is stable (no significant toxicity) from prior dose\n3. Other: Laboratory Biomarker Analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Han, Dr.', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-10-13651392893'}, {'name': 'Daihong Liu, Dr.', 'role': 'CONTACT', 'email': 'daihongrm@163.com', 'phone': '86-10-55499136'}, {'name': 'Weidong Han, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Daihong Liu, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Wenying Zhang', 'role': 'CONTACT', 'email': 'zhangwenying.1984@163.com', 'phone': '86-10-55499341'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Molecular & Immunological Department, Biotherapeutic Department', 'investigatorFullName': 'Han weidong', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}