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

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ClinicalTrials.gov Identifier: NCT04806035
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief 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

Condition or disease Intervention/treatment Phase
CLL SLL Richter's Transformation Indolent Lymphoma Follicular Lymphoma Marginal Zone Lymphoma Aggressive Lymphoma DLBCL Mediastinal Large B-cell Lymphoma MCL Biological: TG-1801 Biological: Ublituximab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase Ib open-label, multi-center, dose-finding study. Once a single-agent dose level is declared safe, the study will evaluate sequentially higher doses of TG-1801 in combination with ublituximab.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 23, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: TG-1801
TG-1801 Single Agent
Biological: TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
Other Name: NI-1701

Experimental: TG-1801 + Ublituximab
TG-1801 in combination with ublituximab
Biological: TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
Other Name: NI-1701

Biological: Ublituximab
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
Other Names:
  • TG-1101
  • LFB-R603




Primary Outcome Measures :
  1. RP2D [ Time Frame: 24 months ]
    To determine the recommended Phase 2 dose (RP2D)


Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
    To evaluate the overall response rate (ORR) of TG-1801 alone and in combination with ublituximab



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04806035


Contacts
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Contact: TG Therapeutics Clinical Support Team 1-877-555-8489 clinicalsupport@tgtxinc.com

Locations
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United States, Arkansas
TG Therapeutics Investigational Trial Site Recruiting
Fayetteville, Arkansas, United States, 72703
United States, New Jersey
TG Therapeutics Investigational Trial Site Recruiting
Hackensack, New Jersey, United States, 07601
United States, Tennessee
TG Therapeutics Investigational Trial Site Recruiting
Chattanooga, Tennessee, United States, 37404
TG Therapeutics Investigational Trial Site Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
TG Therapeutics Investigational Trial Site Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
TG Therapeutics, Inc.
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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04806035    
Other Study ID Numbers: TG-1801-102
First Posted: March 19, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, B-Cell