Aggressive Lymphoma, CLL, DLBCL, Follicular Lymphoma, Indolent Lymphoma, Marginal Zone Lymphoma, MCL, Mediastinal Large B-cell Lymphoma, Richter's Transformation, SLL
Conditions
Brief 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.
Interventions
BIOLOGICALTG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
BIOLOGICALUblituximab
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
Sponsors
TG Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy * Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (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: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (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 centimeters (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 Cycle 1 Day 1. * Prior autologous stem cell transplant (SCT) within 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D | Up to 24 months | To determine the recommended Phase 2 dose (RP2D) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Up to 24 months | To evaluate the overall response rate (ORR) of TG-1801 |
Countries
United States
Outcome results
None listed