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Also known as TL011
TL011, anti CD20, for the treatment of rheumatoid arthritis · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| TL011 | EXPERIMENTAL | - |
| MabThera® | ACTIVE_COMPARATOR | - |
| MabThera | ACTIVE_COMPARATOR | MabThera infusions |
| Name | Type | Description |
|---|---|---|
| TL011 | BIOLOGICAL | 375 mg/m2 iv every 3 weeks for 8 cycles |
| Rituximab | BIOLOGICAL | 375 mg/m2 iv every 3 weeks for 8 cycles |
| TL011, anti CD20, for the treatment of rheumatoid arthritis | BIOLOGICAL | TL011 administered by 2 infusions, 2 weeks apart |
| MabThera infusions | BIOLOGICAL | MabThera, administered by 2 infusions, 2 weeks apart |
Inclusion Criteria: * Newly diagnosed subjects with a confirmed pathologic diagnosis of diffuse large B cell non-Hodgkin's lymphoma (DLBCL) based on the 2008 World Health Organization classification. 2.CD20+ lymphoma cells at screening * 18-80 (inclusive) years of age at screening * Ann Arbor St...
TL011 is an investigational monoclonal antibody developed by Teva Pharmaceutical Industries Limited (ticker: TEVA). It is being studied in Phase 1 clinical trials for CD20-positive diffuse large B-cell lymphoma (DLBCL) and for severe, active rheumatoid arthritis. TL011 is also known as anti-CD20 and has completed two Phase 1 studies.
TL011 is being evaluated for the treatment of severe, active rheumatoid arthritis. A completed Phase 1 trial (NCT01123070) studied TL011 in patients with severe, active rheumatoid arthritis across sites in Czechia, Hungary, Italy, Spain, and the United Kingdom. TL011 is investigational and has not been approved for any indication.
TL011 targets CD20, a protein found on the surface of B cells. As an anti-CD20 monoclonal antibody, TL011 binds to CD20 and is designed to deplete B cells. This mechanism is being explored in both B-cell lymphoma and rheumatoid arthritis, where B cells contribute to disease activity.
TL011 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials evaluating TL011 in DLBCL and rheumatoid arthritis.
TL011 is in Phase 1 clinical development. Two Phase 1 trials have been completed: one in CD20-positive diffuse large B-cell lymphoma (NCT01205737) and one in severe, active rheumatoid arthritis (NCT01123070). TL011 is investigational and has not been approved by the FDA or any regulatory agency.
TL011 has been studied in two completed Phase 1 trials. NCT01205737 was a double-blind, randomized, active-controlled study in CD20-positive diffuse B-cell non-Hodgkin's lymphoma (DLBCL) with 186 participants across ten countries. NCT01123070 studied TL011 in 54 patients with severe, active rheumatoid arthritis in five European countries.