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

  • STATUS
    Recruiting
  • End date
    Dec 20, 2022
  • participants needed
    16
  • sponsor
    TG Therapeutics, Inc.
Updated on 19 January 2022
platelet count
filgrastim
monoclonal antibodies
granulocyte colony stimulating factor
measurable disease
colony stimulating factor
gm-csf
neutrophil count
g-csf
b-cell lymphoma
refractory b-cell non-hodgkin lymphoma
anti-cd20 monoclonal antibody
aggressive non-hodgkin's lymphoma

Summary

Phase 1 first in human Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma

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.

Details
Condition Lymphoma, b cell lymphoma, b cell lymphomas, B-Cell Lymphoma, b-cell lymphomas, Non-Hodgkin's Lymphoma, Lymphoma, B-Cell
Treatment ublituximab, TG-1801
Clinical Study IdentifierNCT03804996
SponsorTG Therapeutics, Inc.
Last Modified on19 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed B-cell lymphoma, relapsed to or refractory after at least one prior standard therapy. For subjects with aggressive lymphoma: those who are non-candidates for high-dose therapy or autologous stem cell transplant. Refractory is defined as disease progression during or within 6 months of the most recent prior therapy, while relapsed is defined as disease progression greater than 6 months after the most recent prior therapy
Measurable disease defined as at least 1 measurable disease lesion 1.5 cm in at least one diameter by CT/CT-PET or magnetic resonance imaging (MRI) in an area of no prior radiation therapy, or in an area that was previously irradiated that has documented progression
Be able to provide a core or excisional lymph node biopsy for biomarker analysis from an archival or newly obtained biopsy at Screening
Adequate organ function defined as
Absolute neutrophil count (ANC) > 1,000/L and platelet count > 75,000/L. Platelet requirements cannot be met by use of recent transfusion (within 30 days of study treatment initiation [Cycle 1 Day 1]). Growth factor support (e.g. G-CSF) is not allowed within 2 weeks prior to treatment initiation
Total bilirubin 1.5 times the ULN, or direct bilirubin ULN for subjects with total bilirubin > 1.5 ULN
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 x ULN if no liver involvement or 5 x the ULN if known liver involvement
Calculated creatinine (Cr) clearance (CL) > 30 mL/min (as calculated by the Cockcroft-Gault or MDRD formula, 24-hour urine Cr CL also acceptable)
Eastern Cooperative Oncology Group (ECOG) performance status 2
Male or female 18 years of age
Female subjects who are not of child-bearing potential (see Appendix B- Contraceptive Guidelines and Pregnancy), and female subjects of child-bearing potential who have a negative serum pregnancy test within 3 days prior to Cycle 1, Day 1. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception throughout the study period and for 4 months after the last dose of study drug. Men of reproductive potential may not participate unless they agree to use medically acceptable contraception
Willingness and ability to comply with trial and follow-up procedures and provide written informed consent

Exclusion Criteria

Prior therapy with any agent blocking the CD47/SIRP pathway or any previous CD19 targeting therapy, including but not limited to: antibodies, fragments, bispecific bodies, or chimeric antigen receptor (CAR) T-cells
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 (42 days for prior mitomycin C or a nitrosourea)
Corticosteroid therapy started at least 7 days prior to Cycle 1 Day 1 (prednisone 10 mg daily or equivalent) is allowed as clinically warranted. Topical or inhaled corticosteroids are permitted
Prior autologous stem cell transplant within 6 months. Prior allogeneic hematologic stem cell transplant within 1 year and excluded if there is active graft versus host disease
Subjects who have not recovered ( Grade 1 or at baseline) from adverse events due to previous therapy, except for alopecia and Grade 2 neuropathy due to previous cancer therapy
Note: Toxicity that has not recovered to Grade 1 is allowed if it meets the
inclusion requirements for laboratory parameters defined above
\. Any severe or uncontrolled illness or other conditions that could affect
their participation in the study including, but not limited to
Symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV) - See Appendix C
Myocardial infarction within 6 months of enrollment
Poorly controlled or clinically significant atherosclerotic vascular disease including cerebrovascular accident, transient ischemic attack, angioplasty, cardiac/vascular stenting within 6 months of enrollment, angina not well controlled by medication
Ongoing or active infection, except localized fungal infection of skin or nails
Known active Hepatitis B (e.g. HBsAg reactive), Hepatitis C (e.g. HCV RNA [qualitative] is detected), cytomegalovirus (CMV DNA by PCR), or known history of HIV
See Appendix D
Malignancy within 2 years of study enrollment except for adequately treated basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, superficial bladder cancer, or localized prostate cancer
Known clinically active CNS involvement
History of anaphylaxis or severe allergy to a monoclonal antibody; or known or suspected hypersensitivity to the excipients contained in the study drug formulation
Lactating or pregnant
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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