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

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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

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

RP2D

Secondary Outcome

 Overall Response Rate

Condition

CLL

Intervention

TG-1801

Study Arms / Comparison Groups

 TG-1801
Description:  TG-1801 Single Agent

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

60

Start Date

April 23, 2021

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 1-877-555-8489, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04806035

Organization ID

TG-1801-102


Responsible Party

Sponsor

Study Sponsor

TG Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

May 2022