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SAR3419

Phase 2

Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |Sanofi|Last Updated: Jan 25, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

SAR3419 · 4 trials · 3 indications

Phase 2 2Phase 1 2
NCT01472887SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) PatientsDiffuse Large B-cell Lymphoma
COMPLETED61 Analytics
NCT01470456Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B-Cell Lymphoma
COMPLETED50 Analytics
PHASE2COMPLETED
SAR3419 as Single Agent in Relapsed-Refractory Diffuse Large B-Cell Lymphoma (DLBCL) Patients
Diffuse Large B-cell LymphomaUnlock trial analytics
PHASE2COMPLETED
Combination of SAR3419 and Rituximab in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants achieving an Objective Response Rate
18 months
Incidence of DLT(s) at each dose level
during the initial 3-week period of treatment
Incidence of Dose Limiting Toxicity(ies) at each tested dose level
Study period

Secondary Endpoints

Number of participants with Adverse Events
Up to 1 year
Response duration - Time
Up to 18 months after the first infusion of the last patient
Progression Free Survival - Time
Up to 18 months after the first infusion of the last patient
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR3419EXPERIMENTALAll patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation
SAR3419 + RituximabEXPERIMENTALCombined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent.

Interventions

NameTypeDescription
SAR3419DRUGPharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
rituximabDRUGPharmaceutical form:solution for infusion Route of administration: intravenous
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion criteria: * Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (\>30% positivity), based on recent (less than 6 months) or new biopsy. * At least 1 prior specific therapeutic regimen, one of w...

Countries:United StatesBelgiumCzechiaIsraelItalyPolandSpainTurkey (Türkiye)United KingdomAustriaFranceNorway
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Frequently asked questions about SAR3419

What is SAR3419 used for?

SAR3419 is an investigational oncology drug being studied for the treatment of B-cell non-Hodgkin's lymphoma, including diffuse large B-cell lymphoma (DLBCL). It has been evaluated in clinical trials for patients with relapsed or refractory disease, both as a single agent and in combination with rituximab.

Who is developing SAR3419?

SAR3419 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker symbol SNY. Sanofi has sponsored clinical trials of SAR3419 in patients with B-cell lymphomas, including diffuse large B-cell lymphoma.

What phase is SAR3419 in?

SAR3419 has completed Phase 2 clinical trials for the treatment of diffuse large B-cell lymphoma. It is an investigational drug that has not been approved by regulatory authorities, and it remains in clinical development. The completed trials include both Phase 1 and Phase 2 studies.

What clinical trials is SAR3419 in?

SAR3419 has been studied in four completed clinical trials. These include NCT00549185 and NCT00796731, both Phase 1 studies in relapsed/refractory B-cell non-Hodgkin's lymphoma, and NCT01470456 and NCT01472887, both Phase 2 studies in relapsed/refractory diffuse large B-cell lymphoma.

How does SAR3419 work?

SAR3419 is a small molecule drug that targets CD19, a protein expressed on B-cells. By binding to CD19, SAR3419 is designed to deliver a cytotoxic payload to malignant B-cells, potentially leading to their death. This mechanism is being investigated for the treatment of B-cell lymphomas.

Is SAR3419 the same as other drugs?

SAR3419 is a unique investigational drug and is not known to be the same as any other approved medication. It is a small molecule that targets CD19, and it has been studied under its own name in clinical trials for B-cell lymphomas.