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Strategic/Business Decision
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Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Cosibelimab (TG-1501) single-agent |
|
| Cohort B | Experimental | Cosibelimab + Ublituximab + Bendamustine combination |
|
| Cohort C | Experimental | Cosibelimab + Ublituximab + Bendamustine combination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosibelimab | Drug | Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events That Are Related to Treatment | Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities | 6 months of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | Objective response in subjects treated with interventions | Up to 12 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TG Therapeutics Investigational Trial Site | Huntsville | Alabama | 35805 | United States | ||
| TG Therapeutics Investigational Trial Site |
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| Cosibelimab + Ublituximab + Bendamustine combination | Drug | Cosibelimab (Intravenous infusion): Cycle 1-6 Days 1&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2&3, Cycles 2-6 Days 1&2. |
|
| Cosibelimab + Ublituximab + Bendamustine combination | Drug | Cosibelimab (Intravenous infusion): Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2&3, Cycles 2-6 Days 1&2. |
|
| Tucson |
| Arizona |
| 85711 |
| United States |
| TG Therapeutics Investigational Trial Site | Fayetteville | Arkansas | 72703 | United States |
| TG Therapeutics Investigational Trial Site | Peoria | Illinois | 61615 | United States |
| TG Therapeutics Investigational Trial Site | Fort Wayne | Indiana | 46804 | United States |
| TG Therapeutics Investigational Trial Site | Fairway | Kansas | 64154 | United States |
| TG Therapeutics Investigational Trial Site | Louisville | Kentucky | 40207 | United States |
| TG Therapeutics Investigational Trial Site | Charlotte | North Carolina | 28262 | United States |
| TG Therapeutics Investigational Trial Site | Seattle | Washington | 98108 | United States |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000619007 | ublituximab |
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