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90Y-hLL2

Phase 2

NHL | Monoclonal antibody | Oncology |Gilead Sciences, Inc.|Trials Updated: Aug 18, 2021

90Y-hLL2 development status

Highest phase Phase 2 run by Amgen (NCT00044902)
Phase scored for GILDPhase 1
Registered trials 11 across 7 sponsors since Sep 2002

90Y-hLL2 target and mechanism

ModalityMonoclonal antibody

Also known as epratuzumab, hLL2, veltuzumab, IMMU-106, hA20, humanized CD20, epratuzumab-tetraxetan, IMMU-102

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment130

FDA Designations

No designations recorded

90Y-hLL2 clinical trials

90Y-hLL2 · 3 trials · 23 indications

Phase 1 3
NCT00546793Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLLNHL
COMPLETED32 Analytics
NCT00596804Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED39 Analytics
NCT00421395Safety Study of NHL With 90Y-hLL2 IgGNHL
COMPLETED59 Analytics
PHASE1COMPLETED
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL
NHLUnlock trial analytics
PHASE1COMPLETED
Safety Study of Different Doses of hA20 (Veltuzumab) in CD20+ Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics
PHASE1COMPLETED
Safety Study of NHL With 90Y-hLL2 IgG
NHLUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety/tolerability
over 2 years after treatment

safety will be assessed by monitoring lab results and adverse events, which will be assessed every 3 months for up to 2 years.

Safety of hA20 with this administration schedule and dosing
first 12 weeks, then over 2 years
tolerance of hA20 with this administration schedule and dosing
first 12 weeks
immunogenicity of hA20 with this administration schedule and dosing
first 12 weeks, as needed over 2 years
Safety will be evaluated from physical examinations, hematology and chemistry testing and toxicity evaluation
First 12 weeks, total 5 years

Secondary Endpoints

Pharmacodynamics of hA20
first 12 weeks, then up to 2 years
pharmacokinetics hA20
first 12 weeks, then up to 2 years
assess efficacy
4 and 12 weeks, then every 3 months for 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
veltuzumabEXPERIMENTALveltuzumab is a humanized CD20 antibody administered subcutaneously in this study.
multiEXPERIMENTALescalating in increments of 2.5 mCi/m2

Interventions

NameTypeDescription
veltuzumabBIOLOGICALveltuzumab (hA20) will be studied at different dose levels, administered subcutaneously once a week for 4 weeks.
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: * Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL) * Either previously untreated or relapsed * Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria Exclusion Criteria:...

Countries:United StatesFranceUnited KingdomGermany
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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.