The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Study of TG-1801 in Subjects With B-Cell Lymphoma
Scientific title
A Phase 1 First-in-Human Study of Bispecific Antibody TG-1801 in Subjects With B-Cell Lymphoma
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-Cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Study type
Description of intervention(s) / exposure
Treatment: Drugs - TG-1801

Experimental: TG-1801 - TG-1801 will be administered as an intravenous infusion over 1 hour, in 4-week (28-day) cycles.

Treatment: Drugs: TG-1801
Intravenous infusion over 1 hour every 4 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Adverse Events That Are Related to Treatment - Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities
Timepoint [1] 0 0
6 months of therapy
Primary outcome [2] 0 0
Overall Response Rate - Objective response in subjects treated with TG-1801
Timepoint [2] 0 0
6 months of therapy

Key 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.
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1

- Prior autologous stem cell transplant within 6 months

- Active Hepatitis B or Hepatitis C

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Olivia Newton-John Cancer Wellness & Research Centre - Heidelberg
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Heidelberg
Recruitment postcode(s) [2] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
TG Therapeutics, Inc.

Ethics approval
Ethics application status

Brief summary
Phase 1 Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
TG Therapeutics Clinical Support Team
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable