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

  • End date
    Dec 17, 2023
  • participants needed
  • sponsor
    TG Therapeutics, Inc.
Updated on 17 October 2022
chronic lymphocytic leukemia
monoclonal antibodies
measurable disease
lymphocytic leukemia
monoclonal protein
b-cell lymphoma
anti-cd20 monoclonal antibody


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

Condition CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Aggressive Lymphoma, DLBCL, Mediastinal Large B-cell Lymphoma, MCL
Treatment ublituximab, TG-1801
Clinical Study IdentifierNCT04806035
SponsorTG Therapeutics, Inc.
Last Modified on17 October 2022


Yes No Not Sure

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
NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
RT subjects: must have relapsed after or be refractory to at least two prior line of therapy for CLL/SLL or RT
CLL subjects: relapsed to or refractory after at least two prior standard therapies
Measurable disease defined as
NHL (including SLL): at least 1 measurable disease lesion > 1.5 cm
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
Clear my responses

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