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

NCT04806035 — Phase 1, Terminated, 21 participants, TG Therapeutics, Inc.
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT04806035
StatusTerminated - Strategic/Business Decision
PhasePhase 1
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment21 (Actual)
SponsorTG Therapeutics, Inc. (Industry)
ConditionsCLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Aggressive Lymphoma, DLBCL, Mediastinal Large B-cell Lymphoma, MCL
InterventionsTG-1801, Ublituximab (Biological)
Datesstart 2021-04-28, primary completion 2024-06-12, completion 2024-06-12, first posted 2021-03-19, last updated 2024-07-31
Locations5 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for CLL All trials for SLL All trials of TG-1801 All trials of Ublituximab

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Cohort A: TG-1801ExperimentalBiological: TG-1801TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.
Cohort B: TG-1801ExperimentalBiological: TG-1801TG-1801 Single Agent, escalating doses
Cohort C: TG-1801 + UblituximabExperimentalBiological: TG-1801; Biological: UblituximabTG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
  • TG-1801 (Biological), also known as NI-1701: It is a bispecific, first-in-class, CD47 and CD19 antibody
  • Ublituximab (Biological), also known as TG-1101, LFB-R603: recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks

+Outcome measures

Primary outcomes

  • RP2D [Up to 24 months]: To determine the recommended Phase 2 dose (RP2D)

Secondary outcomes

  • Overall Response Rate [Up to 24 months]: To evaluate the overall response rate (ORR) of TG-1801

+Eligibility

Sex: All, ages: 18 Years to any

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:

  1. NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
  2. RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (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 centimeters (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 Cycle 1 Day 1.
* Prior autologous stem cell transplant (SCT) within 6 months.

+Locations (5)

FacilityCityCountryStatus
TG Therapeutics Investigational Trial SiteFayetteville, ArkansasUnited States
TG Therapeutics Investigational Trial SiteHackensack, New JerseyUnited States
TG Therapeutics Investigational Trial SiteChattanooga, TennesseeUnited States
TG Therapeutics Investigational Trial SiteNashville, TennesseeUnited States
TG Therapeutics Investigational Trial SiteHouston, TexasUnited States

+Publications

  • Results publication: 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 35538512