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

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

ArmIntervention/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/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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1TG Therapeutics Investigational Trial SiteFayettevilleArkansasUnited States72703
    2TG Therapeutics Investigational Trial SiteHackensackNew JerseyUnited States07601
    3TG Therapeutics Investigational Trial SiteChattanoogaTennesseeUnited States37404
    4TG Therapeutics Investigational Trial SiteNashvilleTennesseeUnited States37203
    5TG Therapeutics Investigational Trial SiteHoustonTexasUnited States77030

    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:
    Mar 23, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 23, 2022