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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03804996




Registration number
NCT03804996
Ethics application status
Date submitted
12/01/2019
Date registered
12/01/2019
Date last updated
8/02/2019

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
TG-1801-101
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
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
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Name
TG Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 1 Study to Assess the Bispecific Antibody TG-1801 in Subjects with B-Cell Lymphoma
Trial website
https://clinicaltrials.gov/show/NCT03804996
Trial related presentations / publications
Public notes

Contacts
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
212-554-4484
Fax 0 0
Email 0 0
clinicalsupport@tgtxinc.com
Contact person for scientific queries

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