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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04923048


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04923048
Ethics application status
Date submitted
4/06/2021
Date registered
11/06/2021
Date last updated
22/05/2023

Titles & IDs
Public title
A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
Scientific title
A Phase ?/?, Open-Label, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GB261 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
GB261-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B Cell NHL 0 0
CLL 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - GB261

Experimental: GB261 - Participants will receive GB261 via intravenous (IV) infusion as a single agent on Day 1, Day 8 and Day 15 of Cycle 1 and 2 followed by Day 1 of each cycle(21 days per cycle) afterwards until disease progression or other situations specified in the protocol, whichever comes earlier.


Other interventions: GB261
Drug:GB261 IV, participants with B-cell NHL or CLL will receive GB261 via IV infusion weekly for the first two cycles(1cycle=21days), followed by Q3W from C3 and afterwards in given doses until progression disease or other situations specified in the protocol, whichever comes earlier.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose
Timepoint [1] 0 0
During Cycle 1 (up to 21 days)
Primary outcome [2] 0 0
Dose Limiting Toxicity
Timepoint [2] 0 0
During Cycle 1 (up to 21 days)
Primary outcome [3] 0 0
Percentage of participants with adverse events
Timepoint [3] 0 0
From first dosing until 90 days after the last treatment
Primary outcome [4] 0 0
Objective Response Rate
Timepoint [4] 0 0
Through study completion, an average of 3 years
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
At predefined intervals up to 106 days
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
At predefined intervals up to 106 days
Secondary outcome [3] 0 0
Area Under the Curve
Timepoint [3] 0 0
At predefined intervals up to 106 days
Secondary outcome [4] 0 0
t1/2
Timepoint [4] 0 0
At predefined intervals up to 106 days
Secondary outcome [5] 0 0
Clearance
Timepoint [5] 0 0
At predefined intervals up to 106 days
Secondary outcome [6] 0 0
Vz
Timepoint [6] 0 0
At predefined intervals up to 106 days
Secondary outcome [7] 0 0
Anti-Drug Antibody
Timepoint [7] 0 0
At predefined intervals up to 3 years
Secondary outcome [8] 0 0
Progression Free Survival
Timepoint [8] 0 0
Through study completion, an average of 3 years
Secondary outcome [9] 0 0
Duration of Objective Response
Timepoint [9] 0 0
Through study completion, an average of 3 years
Secondary outcome [10] 0 0
Duration of Objective Complete Response
Timepoint [10] 0 0
Through study completion, an average of 3 years
Secondary outcome [11] 0 0
Overall Survival
Timepoint [11] 0 0
Through study completion, an average of 3 years

Eligibility
Key inclusion criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

2. CD20+ B-cell Non-Hodgkin Lymphoma or CLL who have relapsed or failed to respond to at
least one prior treatment regimen and for whom there is no available therapy expected
to improve survival

3. Adequate hepatic, hematologic, and renal function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia

2. Prior treatment with systemic anti-lymphoma therapy within 4 weeks or five half-lives
of the drug (which is shorter) prior to the first GB261 infusion

3. History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol
specified conditions

4. Prior allo-SCT or allogeneic CAR-T

5. Prior solid organ transplantation

6. Autoimmune disease with the exceptions specified in the protocol

7. History of central nervous system(CNS) lymphoma or other CNS disease

8. Significant cardiovascular or pulmonary disease

9. Hepatitis B or C or human immunodeficiency virus (HIV)

10. Pregnant or lactating or intending to become pregnant during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/06/2025
Actual
Sample size
Target
460
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,The State Of VIC,The State Of VitoriaWA
Recruitment hospital [1] 0 0
St Vincent's Hospital/The Kinghorn Cancer Centre - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Cabrini hospital - Melbourne
Recruitment hospital [4] 0 0
Alfred hospital - Melbourne
Recruitment hospital [5] 0 0
Peninsula & South Eastern Haematology & Oncology Group - Melbourne
Recruitment hospital [6] 0 0
One Clinical Research Pty Ltd - Mount Pleasant
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3144 - Melbourne
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3199 - Melbourne
Recruitment postcode(s) [6] 0 0
6153 - Mount Pleasant

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genor Biopharma Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1/2 study of GB261 in participants with relapsed or refractory B-cell NHL and
CLL. The study will consist of a dose-escalation stage(Phase 1), an expansion stage(Phase 2a)
and Phase 2b stage where participants will be enrolled into indication-specific cohorts.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04923048
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
Xiao Yu, MD
Address 0 0
Country 0 0
Phone 0 0
021-60751991
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04923048

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 40
Peninsula Oncology Centre
Recruitment postcode(s) [1] 44
3199
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
Genor Biopharma Co. Ltd
Primary sponsor address
1690 Zhangheng Road, Pudong, Shanghai, 200120, China
Primary sponsor country
China
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 38
Bellberry Limited
Address [1] 38
123 Glen Osmond Road Eastwood South Australia 5063
Country [1] 38
Australia
Date submitted for ethics approval [1] 38
17/03/2021
Approval date [1] 38
03/06/2021
Ethics approval number [1] 38
2021-03-270
 
Public notes

Contacts
Principal investigator
Title 281 0
Prof
Name 281 0
Vinod Ganju
Address 281 0
Suite 7, Level 3, North Building, FPH, 5 Susono Way
Country 281 0
Australia
Phone 281 0
+61 412-326-883
Fax 281 0
Email 281 0
[email protected]
Contact person for public queries
Title 282 0
Prof
Name 282 0
Vinod Ganju
Address 282 0
Suite 7, Level 3, North Building, FPH, 5 Susono Way
Country 282 0
Australia
Phone 282 0
+61 412-326-883
Fax 282 0
Email 282 0
[email protected]
Contact person for scientific queries
Title 283 0
Prof
Name 283 0
Vinod Ganju
Address 283 0
Suite 7, Level 3, North Building, FPH, 5 Susono Way
Country 283 0
Australia
Phone 283 0
+61 412-326-883
Fax 283 0
Email 283 0
[email protected]