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B-Cell LymphomaPhase 1NCT03804996

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

A Phase 1 study testing TG-1801 and Ublituximab in people with B-Cell Lymphoma, run by TG Therapeutics, Inc. at 3 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1 first in human Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Lymphoma
What is being tested?
TG-1801 and Ublituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
3 sitesAustralia
Study dates
5 Mar 2019to 21 Feb 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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/µL and platelet count > 75,000/µL. 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.
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  • 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, 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 administration of ublituximab and 30 days after last administration of TG-1801. 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.

Who cannot join

  • Prior therapy with any agent blocking the CD47/SIRPα 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.
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  • 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).
  • 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.
  • 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.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • TG Therapeutics Investigational Trial Site

    Heidelberg, Victoria, 03084

  • TG Therapeutics Investigational Trial Site

    Melbourne, Victoria

  • TG Therapeutics Investigational Trial Site

    Nedlands, Western Australia, 06009

Other trials in Australia

About this study

Official title: A Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma

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

Read the 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.

Conditions
B-Cell Lymphoma
Being tested
TG-1801, Ublituximab
Keywords
relapsed or refractory
Medical subject headings
Lymphoma, B-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG-1801Drug

    Intravenous infusion over 1 hour every 4 weeks

  • UblituximabBiological

    Also called TG-1101, LFB-R603

    "recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks"

Study groups in NCT03804996
Study groupRoleWhat they receive
TG-1801ExperimentalArm Description: TG-1801 will be administered once every 4 weeks (28-day) cycles. Subjects who experience disease progression after completing 6 months of single agent TG-1801 will be eligible for TG-1801 single-agent re-treatment at the discretion of the investigator.
Receives: Drug: TG-1801
TG-1101ExperimentalArm Description: TG-1801 and ublituximab will be administered once every 4 weeks (28-day cycle) for up to 6 cycles followed by TG-1801 monotherapy. To explore the safety of TG-1801 in combination with ublituximab will be explored at doses below and up to the RP2D. TG-1801 intrapatient dose escalation will not be permitted in combination therapy.
Receives: Drug: TG-1801; Biological: Ublituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of Recommended Dose

    To determine the recommended Phase 2 dose (RP2D) by identifying dose limiting toxicity (DLT), maximum tolerable dose (MTD), and optimum biologic dose (OBD).

    Measured: 18 months of therapy

  2. Characterize the Safety Profile of TG-1801

    To characterize the safety profile of TG-1801 alone and in combination with ublituximab by evaluating the adverse event profile.

    Measured: 18 months of therapy

Secondary outcomes (2)

  1. Pharmacokinetic data collection

    To evaluate the pharmacokinetics (PK) of TG-1801 including Cmax.

    Measured: 6 months of therapy

  2. Anticancer activity Evaluation

    To evaluate the preliminary anticancer activity of TG-1801 by evaluating the single-agent arm by assessing the populations of lymphocytes by flow cytometry.

    Measured: 6 months of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start5 Mar 2019
  3. Primary completion21 Feb 2024
  4. Study completion21 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03804996
Sponsor's protocol ID
TG-1801-101
Status last verified
Apr 2024
First submitted
12 Jan 2019
Last updated
8 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TG-1801 and Ublituximab in people with B-Cell Lymphoma, run by TG Therapeutics, Inc. at 3 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of Recommended Dose (time frame: 18 months of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03804996.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.

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