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Cancer Vaccine

TG-1801 + Ublituximab for Lymphoma and Leukemia

Phase 1
Waitlist Available
Research Sponsored by TG Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by iwCLL (Hallek 2018)
NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, TG-1801, alone or in combination with another drug, ublituximab, in people with B-cell lymphoma or chronic lymphocytic leukemia.

Who is the study for?
This trial is for adults with various types of B-cell lymphoma or chronic lymphocytic leukemia that need treatment. They must have tried at least two prior therapies and have measurable disease. People can't join if they've had a certain stem cell transplant recently, cancer therapy within the last 21 days, or previous treatments targeting specific immune pathways.Check my eligibility
What is being tested?
The study is testing TG-1801 alone to find out the safest dose for phase 2 trials in patients with B-cell lymphoma or chronic lymphocytic leukemia. Ublituximab was part of the study but will no longer be used according to the latest protocol update.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system since TG-1801 targets specific cells involved in cancer growth. Patients might experience symptoms like fever, fatigue, infusion-related reactions, and potential changes in blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My CLL requires treatment according to iwCLL guidelines.
Select...
My non-Hodgkin lymphoma didn't respond to at least two treatments.
Select...
My condition is B-cell non-Hodgkin lymphoma needing systemic treatment.
Select...
I have at least one measurable lesion from chronic lymphocytic leukemia.
Select...
I have a lymphoma with a tumor larger than 1.5 cm.
Select...
I have CLL/SLL or RT and my condition didn't improve after at least two treatments.
Select...
My CLL has not improved after at least two treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
RP2D
Secondary outcome measures
Overall Response Rate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: TG-1801 + UblituximabExperimental Treatment2 Interventions
TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
Group II: Cohort B: TG-1801Experimental Treatment1 Intervention
TG-1801 Single Agent, escalating doses
Group III: Cohort A: TG-1801Experimental Treatment1 Intervention
TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ublituximab
2017
Completed Phase 3
~2040

Find a Location

Who is running the clinical trial?

TG Therapeutics, Inc.Lead Sponsor
36 Previous Clinical Trials
5,571 Total Patients Enrolled
12 Trials studying Lymphoma
1,044 Patients Enrolled for Lymphoma

Media Library

TG-1801 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT04806035 — Phase 1
Lymphoma Research Study Groups: Cohort A: TG-1801, Cohort B: TG-1801, Cohort C: TG-1801 + Ublituximab
Lymphoma Clinical Trial 2023: TG-1801 Highlights & Side Effects. Trial Name: NCT04806035 — Phase 1
TG-1801 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04806035 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been previous experimentation with the drug TG-1801?

"Presently, 11 separate trials are exploring the efficacy of TG-1801 with 3 in Phase 3. These clinical studies span across 290 locations, particularly focusing on New york City."

Answered by AI

Is this medical experiment pioneering in its field?

"At this time, 11 ongoing clinical trials are taking place in 133 cities and 13 countries related to the drug TG-1801. The first trial was run byTG Therapeutics, Inc. back in 2015 and included 600 participants who completed Phase 3 of the study with success; since then 9 other similar studies have been initiated."

Answered by AI

Is TG-1801 cleared for public consumption by the Food and Drug Administration?

"The efficacy and safety of TG-1801 have yet to be established, so it was given a score of 1 on our scale. This is due to the fact that this drug is currently in phase 1 trials."

Answered by AI

At what count of sites is this clinical trial currently being managed?

"This research initiative is currently enrolling participants from 5 separate sites. These include Chattanooga, Fayetteville and Nashville in addition to other nearby locations. To reduce the burden of traveling for prospective recruits, it is recommended that they select a clinic most proximal to their residence."

Answered by AI

Are recruitment efforts still taking place for this research study?

"Affirmative. According to the clinicaltrials.gov listing, this medical study began recruiting on April 23rd 2021 and has recently been updated November 18th 2022. 60 patients are needed from 5 separate locations for this trial to be successful."

Answered by AI

How extensive is the participant pool for this investigation?

"Affirmative, the information on clinicaltrials.gov displays that this experiment is actively seeking participants. This investigation was initially published on April 23rd 2021 and updated most recently on November 18th 2022. 60 individuals from five different sites need to be enlisted for it to launch successfully."

Answered by AI
~11 spots leftby Dec 2024