Clinical trial NCT04806035: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: CLL
SLL
Richter's Transformation
Indolent Lymphoma
Follicular Lymphoma
Marginal Zone Lymphoma
Aggressive Lymphoma
DLBCL
Mediastinal Large B-cell Lymphoma
MCL
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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/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.

Primary outcomes:
measure: RP2D
timeFrame: Up to 24 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Arkansas
city: Hackensack
country: United States
facility: TG Therapeutics Investigational Trial Site
state: New Jersey
city: Chattanooga
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Nashville
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Tennessee
city: Houston
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Texas
Study officials:
References:
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.