Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03307746 | A Combination of Rituximab and Varlilumab Immunotherapy in Patients with B-cell Lymphoma | PHASE1 | COMPLETED | 26 | — | — | Nov 23, 2017 | Aug 21, 2024 | Dec 2, 2024 | 4 | United Kingdom |
Causality of each adverse event and grading of severity according to NCI CTCAE version 4.03
Response of disease to treatment assessed at the end of treatment via contrast enhanced CT scan and classified according to the Lugano Revised Response Criteria for Malignant Lymphoma
| Arm | Type | Description |
|---|---|---|
| ARM A- Rituximab and Varlilumab | ACTIVE_COMPARATOR | Patients in ARM A willl receive Cycle1 Day 1: rituximab 375 mg/m2 IV Cycle 1 Day 2: varlilumab 3 mg/kg IV Cycles 2 Day 1: rituximab 375 mg/m2 IV Cycle 3 Day 1: rituximab 375 mg/m2 IV Cycle 3 Day 2: varlilumab 3 mg/kg IV Cycle 4 Day 1: rituximab 375 mg/m2 IV Cycle 5 Day 1: rituximab 375 mg/m2 IV Cycle 5 Day 2: varlilumab 3 mg/kg IV Cycle 6 Day 1: rituximab 375 mg/m2 IV |
| ARM B - Rituximab and Varlilumab | ACTIVE_COMPARATOR | Patients in ARM B will receive Cycle 1 Day 1: rituximab 375 mg/m2 IV Cycle 1 Day 8: varlilumab 3 mg/kg IV Cycle 2 Day 1: rituximab 375 mg/m2 IV Cycle 3 Day 1: rituximab 375 mg/m2 IV Cycle 3 Day 2: varlilumab 3 mg/kg IV Cycle 4 Day 1: rituximab 375 mg/m2 IV Cycle 5 Day 1: rituximab 375 mg/m2 IV Cycle 5 Day 2: varlilumab 3 mg/kg IV Cycle 6 Day 1: rituximab 375 mg/m2 IV |
| Name | Type | Description |
|---|---|---|
| Varlilumab | DRUG | Rituximab is a so-called direct-targeting mAb, which binds to the CD20 molecule on the surface of normal and malignant B cells. The mAb then engages immune effectors cells, such as macrophages, through Fc:Fc gamma receptor interaction, leading to tumour cell killing by antibody directed cellular cytotoxicity and/or phagocytosis (ADCC/ADCP). Varlilumab (1F5, CDX-1127) is a recombinant and fully human IgG1kappa mAb that binds to human CD27 with high affinity (62). As far as we are aware, it is the only anti-CD27 mAb in clinical development. Once bound, varlilumab blocks CD70 binding to CD27. |
Inclusion Criteria: 1. Relapsed or refractory CD20+ B-cell lymphoma excluding chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL). * High grade subgroup: Diffuse large B-cell lymphoma, FL grade 3b, transformed FL * Low grade subgroup: All low grade CD20+ B-cell lymphoma subtyp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Soligenix, Inc. | SNGX | 1 | PHASE3 | Hypericin |
| Incyte Corporation | INCY | 2 | PHASE2 | Ruxolitinib, Pembrolizumab |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | — | Undisclosed |