15 results
PrimaryPhase 1-To characterize the safety and tolerability of isatuximab in combination with cemiplimab in participants with relapsed and refractory cHL, DLBCL or PTCL, and to confirm the recommended Phase 2 dose (RP2D).Phase 2- Cohort A1 (anti-…
Primary Objective:To compare the efficacy in subjects treated with JCAR017 versus subjects treated according to standard of care (SOC) defined as event-free survival (EFS) Key Secondary Objectives:To compare additional parameters of efficacy in…
Primary Objective: Safety Run-in Period:To evaluate the occurrence of tumor lysis syndrome (TLS) and doselimiting toxicities (DLTs) with the concurrent administration of ibrutinib and venetoclax.Randomization Phase:To evaluate whether the…
Primary ObjectivesCohorts 1, 2, 3, 4, and 5• Determine the efficacy, defined as overall response rate (ORR), of JCAR017 in subjects with aggressive B-cell non-Hodgkin lymphomaCohort 7• Evaluate the safety of JCAR017 treatment in subjects intended to…
This study has been transitioned to CTIS with ID 2022-501038-48-00 check the CTIS register for the current data. Primary objective:-To increase 12 months DFS of DH/TH-HGBL patients in CMR after DA-EPOCH-R from 70% to 85% with nivolumab consolidation…
This study has been transitioned to CTIS with ID 2022-501076-26-00 check the CTIS register for the current data. Primary objective:• To evaluate the 2-year disease free survival (DFS)Secondary objectives:• To evaluate toxicity and asses the relation…
This study has been transitioned to CTIS with ID 2023-508343-48-00 check the CTIS register for the current data. To compare tisagenlecleucel treatment strategy to SOC treatment strategy with respect to delaying the composite event of disease…
This study has been transitioned to CTIS with ID 2023-504201-36-00 check the CTIS register for the current data. Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, lentiviral vectors), long-term…
This study has been transitioned to CTIS with ID 2023-504802-12-00 check the CTIS register for the current data. Dose Escalation Objectives:Primary:* Determine maximum tolerated dose (MTD) and RP2DSecondary:* Establish tolerability of epcoritamab*…
This study has been transitioned to CTIS with ID 2023-508127-13-00 check the CTIS register for the current data. This single arm, multi-center, phase II study will determine the efficacy and safety of tisagenlecleucel in adult patients with FL who…
Within the immunotherapy group, a new panel of anti-CD20 monoclonals have been generated that are currently produced as chimeric IgG and IgA formats. We intend to demonstrate the efficacy and the anticipated superiority of IgA versus IgG and…
1 - To determine the feasibility of MRD detection using next generation sequencing (NGS) on circulating tumor DNA (ctDNA) from PTLD patients using a gene panel previously used in diffuse large B-cell lymphoma (DLBCL) 2 - To explore the mutational…
Primary objective:• To evaluate biodistribution of 89Zr-atezolizumab in patients with high risk DLBCL at diagnosis.Secondary objective:• To assess the heterogeneity of 89Zr-atezolizumab tumor uptake in high-risk DLBCL before R-CHOP.• To correlate…
Phase 1:To identify the recommended Phase 2 dose (RP2D) of JCAR017 in pediatric subjects withCD19+ r/r B-ALL.Phase 2:To evaluate the following efficacy endpoints of the JCAR017 RP2D identified in Phase 1, in the following three diseasecohorts:•…
To clarify the pathophysiological genetic pathway of the association between C. burnetii and NHL