Chronic Lymphocytic Leukemia Clinical Trial

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

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

View Eligibility Criteria

Eligibility Criteria

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 (leukemia-cll/" >CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) (Hallek 2018)

Treatment Status:

NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (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 centimeters (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 Cycle 1 Day 1.
Prior autologous stem cell transplant (SCT) within 6 months.

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04806035

Recruitment Status:

Active, not recruiting

Sponsor:

TG Therapeutics, Inc.

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There are 5 Locations for this study

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TG Therapeutics Investigational Trial Site
Fayetteville Arkansas, 72703, United States
TG Therapeutics Investigational Trial Site
Hackensack New Jersey, 07601, United States
TG Therapeutics Investigational Trial Site
Chattanooga Tennessee, 37404, United States
TG Therapeutics Investigational Trial Site
Nashville Tennessee, 37203, United States
TG Therapeutics Investigational Trial Site
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT04806035

Recruitment Status:

Active, not recruiting

Sponsor:


TG Therapeutics, Inc.

How clear is this clinincal trial information?

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