CLINICAL TRIAL: CAT-8015 IN PATIENTS WITH RELAPSED OR REFRACTORY HAIRY CELL LEUK
CLINICAL TRIAL: CAT-8015 IN PATIENTS WITH RELAPSED OR REFRACTORY HAIRY CELL LEUK
批准号:
7717934
负责人:
STEVEN E COUTRE
金额:
$0.07万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2007
资助国家:
美国
项目状态:
已结题
起止时间:
2007-12-01 至 2008-05-31
关键词:
ADP ribosylationAccountingAffinityAntibodiesBindingCD22 geneCell DeathCellsCladribineClinical ResearchClinical TrialsComplexComputer Retrieval of Information on Scientific Projects DatabaseCytosolDiseaseDisulfidesDose-LimitingDrug KineticsEndocytosisExotoxinsFelis catusFundingGrantHairy Cell LeukemiaHairy cellHumanImmunosuppressionIndolentInfectionInstitutionMalignant NeoplasmsMarrowMaximum Tolerated DoseMedicalMonoclonal AntibodiesMusPartial RemissionPatientsPeptide Elongation Factor 2Progressive DiseasePseudomonasRateRecombinantsRefractoryRelapseResearchResearch PersonnelResourcesRetreatmentRiskSafetySourceStandards of Weights and MeasuresTherapeutic immunosuppressionToxic effectUnited States National Institutes of Healthantibody conjugatechemotherapycytopeniadesignimmunogenicityleukemianeurotoxicityresponse
中文摘要
这个子项目是众多研究子项目之一
英文摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
Hairy cell leukemia (HCL) is a rare lymphoproliferative malignancy accounting for approximately 2% of all leukemias. Standard treatment is a single course of 2-chlorodeoxyadenosine (2-CdA) with complete or partial remission rates of 70%. Response rates after retreatment with 2-CdA are similar but less durable. Repetitive administration carries risks including immunosuppression, marrow aplasia, prolonged cytopenias, infections and neurotoxicity.
HCL cells express high levels of CD22. The investigational agent used in this study, CAT-8015, is a recombinant, disulfide-stabilized Fv of the murine monoclonal antibody anti-CD22 antibody, RFB4, fused to a truncated form of pseudomonas exotoxin, PE38. CAT-8015 binds to CD22 and the complex is internalized by endocytosis. The exotoxin domain is translocated to the cytosol where it catalyzes the ADP ribosylation of elongation factor 2, resulting in cell death.
CAT-8015 has not been previously studied in humans, but a similar antibody conjugate, CAT-3888 has demonstrated significant activity in clinical studies of relapsed, refractory HCL. CAT-8015 was designed to have greater binding affinity for CD-22 than CAT-3888.
The primary objective of this study is to identify the dose-limiting toxicity and maximum tolerated dose of CAT-8015 in patients with relapsed or refractory HCL. Safety, efficacy, pharmacokinetics and immunogenicity of CAT-8015 will be profiled. Although HCL is an indolent disease, all patients in this study will have advanced disease that has failed standard chemotherapy and will have medical indications for treatment of progressive disease.
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SHEPHERD: SAFETY IN HEMOLYTIC PNH PATIENTS TREATED WITH ECULIZUMAB
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批准号:7605233
-
项目类别:
-
资助金额:$2.34万
-
财政年份:2007
-
负责人:STEVEN E COUTRE
-
依托单位:
ECULIZUMAB IN PATIENTS WITH TRANSFUSION DEPENDANT, HEMOLYTIC PNH
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批准号:7605234
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项目类别:
-
资助金额:$3.22万
-
财政年份:2007
-
负责人:STEVEN E COUTRE
-
依托单位:
ADULT PATIENTS W/ RELAPSED OR REFRACTORY B-LINEAGE ACUTE LYMPHOBLASTIC LEUKEMIA
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批准号:7605250
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项目类别:
-
资助金额:$0.7万
-
财政年份:2007
-
负责人:STEVEN E COUTRE
-
依托单位:
CLINICAL TRIAL: ADULT PATIENTS W/RELAPSED OR REFRACTORY B-LINEAGE ACUTE LYMPHOBL
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批准号:7717899
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项目类别:
-
资助金额:$0.06万
-
财政年份:2007
-
负责人:STEVEN E COUTRE
-
依托单位:
CLINICAL TRIAL: ECULIZUMAB IN PATIENTS WITH TRANSFUSION DEPENDANT, HEMOLYTIC (PN
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批准号:7717886
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项目类别:
-
资助金额:$0.26万
-
财政年份:2007
-
负责人:STEVEN E COUTRE
-
依托单位:
SHEPHERD: SAFETY IN HEMOLYTIC PNH PATIENTS TREATED WITH ECULIZUMAB
-
批准号:7375309
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项目类别:
-
资助金额:$0.8万
-
财政年份:2005
-
负责人:STEVEN E COUTRE
-
依托单位:
PATIENTS WITH TRANSFUSION DEPENDANT (PNH)
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批准号:7375310
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项目类别:
-
资助金额:$0.89万
-
财政年份:2005
-
负责人:STEVEN E COUTRE
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依托单位:
USING ECULIZUMAB IN PAROXYSMAL NOCTURNAL HEMOGLOBINURIA PATIENTS
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批准号:7375282
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项目类别:
-
资助金额:$0.93万
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财政年份:2005
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负责人:STEVEN E COUTRE
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依托单位:
ANTIB1 ANTIBODY FOR B CELL CHRONIC LYMPHOCYTIC LEUKEMIA
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批准号:6486086
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项目类别:
-
资助金额:$13.47万
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财政年份:2000
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负责人:STEVEN E COUTRE
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依托单位:
FUNCTIONAL CONSEQUENCES OF NATURAL HIV-1 ENV GENE DIVERS
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批准号:3085434
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项目类别:
-
资助金额:$4.07万
-
财政年份:1992
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负责人:STEVEN E COUTRE
-
依托单位:
海外基金