Clinical trial · Interventional
SAR3419 Administered Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma
A Dose-escalation, Safety and Pharmacokinetic Study of SAR3419 Administered as a Single Agent by Intravenous Infusion Once Weekly in Patients With Relapsed/Refractory CD19-positive B-cell Non-Hodgkin's Lymphoma (NHL)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective is to determine the maximum tolerated dose (MTD) of SAR3419 according to the dose limiting toxicities (DLTs) observed when administered as a single agent once weekly. Secondary objectives are: * to characterize the global safety profile * to evaluate the pharmacokinetic (PK) profile of SAR3419 in the proposed dosing schedule * to assess preliminary evidence of anti-lymphoma activity.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin | B-Cell Malignant Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SAR3419 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of DLT(s) at each dose level
- timeFrame
- during the initial 3-week period of treatment
Secondary outcomes (4)
- measure
- Cumulative DLT(s)
- timeFrame
- over the entire period of treatment
- measure
- Incidence of Adverse Events and laboratory abnormalities
- timeFrame
- study period
- measure
- Tumor response (complete response, partial response) and duration of the response
- timeFrame
- study period
- measure
- Pharmacokinetics parameters
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of B-cell non Hodgkin's lymphoma * Relapsed or refractory after standard treatments and with no curative option with conventional therapy (Patients having undergone stem cell transplantation may be included) * CD19 positive disease by flow cytometry or immunohistochemistry Exclusion Criteria: * Burkitt's lymphoma, Lymphoblastic lymphoma, Chronic lymphocytic leukemia (Small lymphocytic lymphoma may be included) * Evidence of cerebral or meningeal involvement by lymphoma * Patients without bi-dimensionally measurable disease * ECOG performance status \> 2 * Life expectancy less than 3 months * Chemotherapy or radiation therapy or other investigational agents within 4 weeks prior to entering the study * Previous radioimmunotherapy within 12 weeks * Known anaphylaxis to infused proteins * HIV, HBV and HCV positivity * Poor kidney, liver and bone marrow functions * Any serious active disease or co-morbid condition, which, in the opinion of the principle investigator, will interfere with the safety or the compliance with the study * Pregnant or breast-feeding women * Patients with reproductive potential without effective birth control methods The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available