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SAR3419 · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| SAR3419 | EXPERIMENTAL | All patients will receive SAR3419 until evidence of disease progression, unacceptable toxicity, or other reasons for therapy discontinuation |
| SAR3419 + Rituximab | EXPERIMENTAL | Combined therapy will be administered intravenously for 8 doses in the absence of unacceptable toxicity, disease progression or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| SAR3419 | DRUG | Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous |
| rituximab | DRUG | Pharmaceutical form:solution for infusion Route of administration: intravenous |
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...
SAR3419 is an investigational therapy developed for B-cell lymphomas, including relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and CD19-positive B-cell non-Hodgkin's lymphoma. It has been studied both as a single agent and in combination with rituximab in adult patients whose disease has returned or not responded to prior treatment.
SAR3419 is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the clinical trial program evaluating SAR3419 in B-cell lymphoma, including Phase 1 and Phase 2 studies conducted across the United States, Europe, and other regions.
SAR3419 has completed Phase 2 clinical development. Two Phase 2 trials and two Phase 1 trials have been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
SAR3419 has been evaluated in four completed clinical trials. Phase 2 studies include NCT01472887, which tested SAR3419 as a single agent in relapsed or refractory DLBCL, and NCT01470456, which combined SAR3419 with rituximab. Phase 1 studies NCT00796731 and NCT00549185 evaluated SAR3419 in relapsed or refractory B-cell non-Hodgkin's lymphoma.
Across the four completed clinical trials, 227 patients have been enrolled. The Phase 2 trial NCT01472887 enrolled 61 patients, NCT01470456 enrolled 50, the Phase 1 trial NCT00796731 enrolled 77, and the Phase 1 trial NCT00549185 enrolled 39. All participants were adults aged 18 years or older.
Yes, SAR3419 trials have used biomarker selection. The clinical program focused on patients with CD19-positive B-cell malignancies, including diffuse large B-cell lymphoma and non-Hodgkin's lymphoma, meaning eligibility was tied to expression of the CD19 biomarker on tumor cells.