Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    60
  • sponsor
    TG Therapeutics, Inc.
Updated on 4 May 2022
chronic lymphocytic leukemia
lymphoma
monoclonal antibodies
measurable disease
leukemia
lymphocytic leukemia
monoclonal protein
b-cell lymphoma
anti-cd20 monoclonal antibody

Summary

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

Details
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 on4 May 2022

Eligibility

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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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