NCT04806035

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2021

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 28, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

3.1 years

First QC Date

March 5, 2021

Last Update Submit

July 29, 2024

Conditions

CLLSLLRichter's TransformationIndolent LymphomaFollicular LymphomaMarginal Zone LymphomaAggressive LymphomaDLBCLMediastinal Large B-cell LymphomaMCL

Outcome Measures

Primary Outcomes (1)

  • RP2D

    To determine the recommended Phase 2 dose (RP2D)

    Up to 24 months

Secondary Outcomes (1)

  • Overall Response Rate

    Up to 24 months

Study Arms (3)

Cohort A: TG-1801

EXPERIMENTAL

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

Biological: TG-1801

Cohort B: TG-1801

EXPERIMENTAL

TG-1801 Single Agent, escalating doses

Biological: TG-1801

Cohort C: TG-1801 + Ublituximab

EXPERIMENTAL

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

Biological: TG-1801Biological: Ublituximab

Interventions

TG-1801BIOLOGICAL

It is a bispecific, first-in-class, CD47 and CD19 antibody

Also known as: NI-1701
Cohort A: TG-1801Cohort B: TG-1801Cohort C: TG-1801 + Ublituximab
UblituximabBIOLOGICAL

recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks

Also known as: TG-1101, LFB-R603
Cohort C: TG-1801 + Ublituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

TG Therapeutics Investigational Trial Site

Fayetteville, Arkansas, 72703, United States

Location

TG Therapeutics Investigational Trial Site

Hackensack, New Jersey, 07601, United States

Location

TG Therapeutics Investigational Trial Site

Chattanooga, Tennessee, 37404, United States

Location

TG Therapeutics Investigational Trial Site

Nashville, Tennessee, 37203, United States

Location

TG Therapeutics Investigational Trial Site

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 35538512DERIVED

MeSH Terms

Conditions

Lymphoma, FollicularLymphoma, B-Cell, Marginal Zone

Interventions

ublituximabLFB-R603

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-Cell

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 19, 2021

Study Start

April 28, 2021

Primary Completion

June 12, 2024

Study Completion

June 12, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

US(5)