Description:
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
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
Recruiting
Phase 1
Drug | Synonyms | Arms |
---|---|---|
TG-1801 | NI-1701 | TG-1801 |
Ublituximab | TG-1101, LFB-R603 | TG-1801 + Ublituximab |
Name | Type | Description | Interventions |
---|---|---|---|
TG-1801 | Experimental | TG-1801 Single Agent |
|
TG-1801 + Ublituximab | Experimental | TG-1801 in combination with ublituximab |
|
Inclusion Criteria: - B-cell non-Hodgkin lymphoma (NHL) including RT and transformed FL, that warrants systemic therapy - Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by iwCLL (Hallek 2018) - Treatment Status: 1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics) 2. RT subjects: must have relapsed after or be refractory to at least two prior line of therapy for CLL/SLL or RT 3. CLL subjects: relapsed to or refractory after at least two prior standard therapies - Measurable disease defined as: 1. NHL (including SLL): at least 1 measurable disease lesion > 1.5 cm 2. CLL: at least 1 measurable disease lesion Exclusion Criteria: - Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19 targeting therapy, - Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) or any investigational drug within 21 days of Day 1 of Cycle 1 - Prior autologous SCT within 6 months.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | RP2D |
Time Frame: | 24 months |
Safety Issue: | |
Description: | To determine the recommended Phase 2 dose (RP2D) |
Measure: | Overall Response Rate |
Time Frame: | 24 months |
Safety Issue: | |
Description: | To evaluate the overall response rate (ORR) of TG-1801 alone and in combination with ublituximab |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | TG Therapeutics, Inc. |
August 23, 2021