Trials / Terminated
TerminatedNCT04806035
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.
Conditions
- CLL
- SLL
- Richter's Transformation
- Indolent Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Aggressive Lymphoma
- DLBCL
- Mediastinal Large B-cell Lymphoma
- MCL
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TG-1801 | It is a bispecific, first-in-class, CD47 and CD19 antibody |
| BIOLOGICAL | Ublituximab | recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks |
Timeline
- Start date
- 2021-04-28
- Primary completion
- 2024-06-12
- Completion
- 2024-06-12
- First posted
- 2021-03-19
- Last updated
- 2024-07-31
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04806035. Inclusion in this directory is not an endorsement.