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Ofatumumab combined with SB-485232

Phase 1

Non-Hodgkin's Lymphoma | Monoclonal antibody | Oncology |Novartis AG|Trials Updated: Feb 10, 2023

Ofatumumab combined with SB-485232 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Ofatumumab combined with SB-485232 clinical trials

Ofatumumab combined with SB-485232 · 1 trial · 1 indication

Phase 1 1
NCT01768338Recombinant Human IL-18 and Ofatumumab After PBSCT for LymphomaNon-Hodgkin's Lymphoma
COMPLETED9 Analytics
PHASE1COMPLETED
Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma
Non-Hodgkin's Lymphoma
NCT017683389
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Study Endpoints

Primary Endpoints

To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
8 weeks

Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).

Secondary Endpoints

To evaluate the biologic effects of SB-485232 given in combination with ofatumumab
8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Ofatumumab combined with SB-485232EXPERIMENTALOtatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.

Interventions

NameTypeDescription
Ofatumumab combined with SB-485232DRUGOfatumumab with escalating doses of SB-485232
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma. * Patients must be between 2-6 months post-transplantation at the time of study registration. * Patients must have at least stable disease (no overt progressive disease) at the ...

Countries:United States
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