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

Sponsor
TG Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04806035
Collaborator
(none)
60
Enrollment
5
Locations
2
Arms
31.3
Anticipated Duration (Months)
12
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Biological: TG-1801
  • Biological: Ublituximab
 Phase 1

Study Design

Study Type:
Interventional
Anticipated 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.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 :
Apr 23, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. RP2D [24 months]

      To determine the recommended Phase 2 dose (RP2D)

    Secondary Outcome Measures

    1. Overall Response Rate [24 months]

      To evaluate the overall response rate (ORR) of TG-1801 alone and in combination with ublituximab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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/SIRPĪ± 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 TG Therapeutics Investigational Trial Site Fayetteville Arkansas United States 72703
    2 TG Therapeutics Investigational Trial Site Hackensack New Jersey United States 07601
    3 TG Therapeutics Investigational Trial Site Chattanooga Tennessee United States 37404
    4 TG Therapeutics Investigational Trial Site Nashville Tennessee United States 37203
    5 TG Therapeutics Investigational Trial Site Houston Texas United States 77030

    Sponsors and Collaborators

    • TG Therapeutics, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    TG Therapeutics, Inc.
    ClinicalTrials.gov Identifier:
    NCT04806035
    Other Study ID Numbers:
    • TG-1801-102
    First Posted:
    Mar 19, 2021
    Last Update Posted:
    Aug 22, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma
    Leukemia, Lymphoid
    Lymphoma, B-Cell
    Leukemia, Lymphocytic, Chronic, B-Cell

    Study Results

    No Results Posted as of Aug 22, 2022