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Study of TG-1801 in Subjects With B-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03804996
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Brief Summary:
Phase 1 Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma

Condition or disease Intervention/treatment Phase
B-Cell Lymphoma Drug: TG-1801 Phase 1

Detailed Description:
This is an open-label, multi-center, accelerated titration design study. Planned enrollment includes 1 subject at low dose levels. Subjects will receive weekly infusions of TG-1801 in a 4 week-cycles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: TG-1801
TG-1801 will be administered as an intravenous infusion over 1 hour, in 4-week (28-day) cycles.
Drug: TG-1801
Intravenous infusion over 1 hour every 4 weeks




Primary Outcome Measures :
  1. Adverse Events That Are Related to Treatment [ Time Frame: 6 months of therapy ]
    Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities

  2. Overall Response Rate [ Time Frame: 6 months of therapy ]
    Objective response in subjects treated with TG-1801



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed relapsed or refractory B-cell lymphoma
  • Measurable disease and adequate organ function as specified in the protocol
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.

Exclusion Criteria:

  • Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1 Day
  • Prior autologous stem cell transplant within 6 months
  • Active Hepatitis B or Hepatitis C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03804996


Contacts
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Contact: TG Therapeutics Clinical Support Team 212-554-4484 clinicalsupport@tgtxinc.com

Locations
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Australia
Olivia Newton-John Cancer Wellness & Research Centre Recruiting
Heidelberg, Australia
The Alfred Hospital Recruiting
Melbourne, Australia
Contact: Sushrut Patil, FRACP, FRCPA         
Sponsors and Collaborators
TG Therapeutics, Inc.

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Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03804996     History of Changes
Other Study ID Numbers: TG-1801-101
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TG Therapeutics, Inc.:
relapsed or refractory

Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin