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90Y-hLL2

Phase 1

NHL | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 16, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment59

FDA Designations

No designations recorded

Clinical trial landscape

90Y-hLL2 · 1 trial · 3 indications

Phase 1 1
NCT00421395Safety Study of NHL With 90Y-hLL2 IgGNHL
COMPLETED59 Analytics
PHASE1COMPLETED
Safety Study of NHL With 90Y-hLL2 IgG
NHLUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation
First 12 weeks, total 5 years

Secondary Endpoints

Determine maximum tolerated dose (MTD)
first 12 weeks
Evaluate the immunogenicity and safety of repeated infusions of 90Y-hLL2 in NHL patients.
6 weeks, 12 weeks, every 3 months if HAHA elevated
Determine the therapeutic effects, in terms of objective response rate and duration, of the therapeutic agent in NHL patients.
6 wks, 12 wks, every 3 mos for 5 years
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
multiEXPERIMENTALescalating in increments of 2.5 mCi/m2

Interventions

NameTypeDescription
90Y-hLL2BIOLOGICALweekly dosing for either 2 or 3 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * All patients must have a histologic or cytological diagnosis of B-cell lymphoma, and have failed at least one regimen of standard chemotherapy. All histologic grades of non-Hodgkin's lymphoma (NHL) will be eligible for these studies. * Patients must be \> 18 years of age * Mea...

Countries:FranceGermany
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Frequently asked questions about 90Y-hLL2

What is 90Y-hLL2 used for?

90Y-hLL2 is an investigational monoclonal antibody being studied for the treatment of non-Hodgkin lymphoma (NHL), including B-cell NHL. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing 90Y-hLL2?

90Y-hLL2 is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The drug is an investigational monoclonal antibody in Phase 1 clinical development for the treatment of non-Hodgkin lymphoma.

What phase is 90Y-hLL2 in?

90Y-hLL2 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. A Phase 1 safety study of 90Y-hLL2 in patients with non-Hodgkin lymphoma has been completed.

What clinical trials is 90Y-hLL2 in?

90Y-hLL2 has one completed clinical trial, NCT00421395, a Phase 1 safety study in patients with non-Hodgkin lymphoma, including B-cell NHL. The study enrolled 59 participants and was conducted in France and Germany.

Is 90Y-hLL2 the same as hLL2?

90Y-hLL2 is a radiolabeled form of the monoclonal antibody hLL2, where the antibody is conjugated to the radioisotope yttrium-90. The drug is being studied for its potential to deliver radiation directly to cancer cells in non-Hodgkin lymphoma.