Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-03-13 @ 2:30 PM
Study NCT ID:
NCT01864902
Status:
UNKNOWN
Last Update Posted:
2016-01-28
First Post:
2013-05-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Relapsed and/or Chemotherapy Refractory CD33 Positive Acute Myeloid Leukemia by CART-33
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}, {'id': 'D012680', 'term': 'Sensitivity and Specificity'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'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'}]}}, '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': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-26', 'studyFirstSubmitDate': '2013-05-20', 'studyFirstSubmitQcDate': '2013-05-26', 'lastUpdatePostDateStruct': {'date': '2016-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'in vivo existence of CART33', 'timeFrame': '1 year'}], 'primaryOutcomes': [{'measure': 'Occurrence of study related adverse events', 'timeFrame': 'Until week 24', 'description': 'defined as \\>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment'}], 'secondaryOutcomes': [{'measure': 'Anti-leukemia responses to CART-33 cell infusions', 'timeFrame': 'up to 24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CD33 positive acute myeloid leukemia (AML)'], 'conditions': ['Relapsed Adult Myeloid Leukemia', 'Chemotherapy Refractory Adult Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '25174587', 'type': 'DERIVED', 'citation': 'Wang QS, Wang Y, Lv HY, Han QW, Fan H, Guo B, Wang LL, Han WD. Treatment of CD33-directed chimeric antigen receptor-modified T cells in one patient with relapsed and refractory acute myeloid leukemia. Mol Ther. 2015 Jan;23(1):184-91. doi: 10.1038/mt.2014.164. Epub 2014 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.\n\nPURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD33 vector (referred to as CART-33 cells).\n\nII. Determine duration of in vivo survival of CART-33 cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-33 TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.\n\nSECONDARY OBJECTIVES:\n\nI. For patients with detectable disease, measure anti-leukemia response due to CART-33 cell infusions.\n\nII. To determine if the CD137 transgene is superior to the TCR zeta only transgene as measured by the relative engraftment levels of CART-33 TCR zeta:CD137 and TCR zeta cells over time.\n\nIII. Estimate relative trafficking of CART-33 cells in bone marrow.\n\nIV. For patients with stored or accessible leukemia blasts, determine leukemia cell killing by CART-33 cells in vitro.\n\nV. Determine if cellular or humoral host immunity develops against the murine anti-CD33, and assess correlation with loss of detectable CART-33 (loss of engraftment).\n\nVI. Determine the relative subsets of CART-33 T cells (Tcm, Tem, and Treg).\n\nOUTLINE: Patients are assigned to 1 group according to order of enrollment.\n\nPatients receive anti-CD33-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of disease progression or unacceptable toxicity.\n\nAfter completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \\< 2 year survival) with currently available therapies will be enrolled\n\n * CD33+ acute myeloid leukemia CR can not be achieved after at least 2 prior combination chemotherapy regimens.\n\nAML in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor.\n\nLess than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \\< 1 year).\n\nRelapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.\n\nResidual disease after primary therapy and not eligible for autologous SCT\n\n* Expected survival \\> 12 weeks\n* Creatinine \\< 2.5 mg/dl\n* ALT(alanine aminotransferase)/AST (aspartate aminotransferase)\\< 3x normal\n* Bilirubin \\< 2.0 mg/dl\n* Any relapse after prior SCT will make patient eligible regardless of other prior therapy\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n\n * The safety of this therapy on unborn children is not known\n * Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion\n * Uncontrolled active infection\n * Active hepatitis B or hepatitis C infection\n * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary\n * Previously treatment with any gene therapy products\n * Feasibility assessment during screening demonstrates \\< 30% transduction of target lymphocytes, or insufficient expansion (\\< 5-fold) in response to CD3/CD137 costimulation\n * Any uncontrolled active medical disorder that would preclude participation as outlined\n * HIV infection'}, 'identificationModule': {'nctId': 'NCT01864902', 'acronym': 'CART33', 'briefTitle': 'Treatment of Relapsed and/or Chemotherapy Refractory CD33 Positive Acute Myeloid Leukemia by CART-33', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Study of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Acute Myeloid Leukemias', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-CD33 CAR T cells', 'description': 'Patients receive anti-CD33-CAR retroviral vector-transduced autologous or donor-derived T cells on days 0,1, 2 in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Biological: CART33 cells', 'Biological: anti-CD33 CART', 'Biological: anti-CD33 CAR T cells']}], 'interventions': [{'name': 'CART33 cells', 'type': 'BIOLOGICAL', 'otherNames': ['chimeric antigen receptor T cells with specificity for CD33'], 'description': 'genetically modified lymphocyte therapy', 'armGroupLabels': ['anti-CD33 CAR T cells']}, {'name': 'anti-CD33 CART', 'type': 'BIOLOGICAL', 'otherNames': ['CART33'], 'armGroupLabels': ['anti-CD33 CAR T cells']}, {'name': 'anti-CD33 CAR T cells', 'type': 'BIOLOGICAL', 'armGroupLabels': ['anti-CD33 CAR T cells']}]}, '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': 'Xuliang Shen, Dr.', 'role': 'CONTACT', 'email': 'shenxlcyp@sohu.com', 'phone': '86-355-13015365546'}, {'name': 'Ying Liu, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yao Wang, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital, Hematological Department, Affiliated Hospital of Changzhi Medical College', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Weidong Han, Dr.', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-10-13651392893'}, {'name': 'Xuliang Shen, Dr.', 'role': 'CONTACT', 'email': 'shenxlcyp@sohu.com', 'phone': '86-355-13015365546'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Han weidong', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}