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

Primary Purpose

CLL, SLL, Richter's Transformation

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TG-1801
Ublituximab
Sponsored by
TG Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • TG Therapeutics Investigational Trial SiteRecruiting
  • TG Therapeutics Investigational Trial SiteRecruiting
  • TG Therapeutics Investigational Trial SiteRecruiting
  • TG Therapeutics Investigational Trial SiteRecruiting
  • TG Therapeutics Investigational Trial SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A: TG-1801

Cohort B: TG-1801

Cohort C: TG-1801 + Ublituximab

Arm Description

TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.

TG-1801 Single Agent, escalating doses

TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.

Outcomes

Primary Outcome Measures

RP2D
To determine the recommended Phase 2 dose (RP2D)

Secondary Outcome Measures

Overall Response Rate
To evaluate the overall response rate (ORR) of TG-1801

Full Information

First Posted
March 5, 2021
Last Updated
October 9, 2023
Sponsor
TG Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04806035
Brief Title
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 23, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Aggressive Lymphoma, DLBCL, Mediastinal Large B-cell Lymphoma, MCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: TG-1801
Arm Type
Experimental
Arm Description
TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.
Arm Title
Cohort B: TG-1801
Arm Type
Experimental
Arm Description
TG-1801 Single Agent, escalating doses
Arm Title
Cohort C: TG-1801 + Ublituximab
Arm Type
Experimental
Arm Description
TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
Intervention Type
Biological
Intervention Name(s)
TG-1801
Other Intervention Name(s)
NI-1701
Intervention Description
It is a bispecific, first-in-class, CD47 and CD19 antibody
Intervention Type
Biological
Intervention Name(s)
Ublituximab
Other Intervention Name(s)
TG-1101, LFB-R603
Intervention Description
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
Primary Outcome Measure Information:
Title
RP2D
Description
To determine the recommended Phase 2 dose (RP2D)
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To evaluate the overall response rate (ORR) of TG-1801
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TG Therapeutics Clinical Support Team
Phone
1-877-555-8489
Email
clinicalsupport@tgtxinc.com
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Individual Site Status
Recruiting
Facility Name
TG Therapeutics Investigational Trial Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
TG Therapeutics Investigational Trial Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Individual Site Status
Recruiting
Facility Name
TG Therapeutics Investigational Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
TG Therapeutics Investigational Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
35538512
Citation
Chauchet X, Cons L, Chatel L, Daubeuf B, Didelot G, Moine V, Chollet D, Malinge P, Pontini G, Masternak K, Ferlin W, Buatois V, Shang L. CD47xCD19 bispecific antibody triggers recruitment and activation of innate immune effector cells in a B-cell lymphoma xenograft model. Exp Hematol Oncol. 2022 May 10;11(1):26. doi: 10.1186/s40164-022-00279-w.
Results Reference
derived

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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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