B Cell NHLPhase 1/2NCT04923048
A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
A Phase 1/2 study testing GB261 in people with B Cell NHL and CLL, run by Genor Biopharma Co., Ltd. at 6 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell NHL, CLL
- What is being tested?
- GB261
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 6 sitesAustralia
- Study dates
- 31 Aug 2021to 28 Jun 2025
- Phase
- Phase 1/2
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Adequate hepatic, hematologic, and renal function
Who cannot join
- Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia
- 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
- History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions
- Prior allo-SCT or allogeneic CAR-T
- Prior solid organ transplantation
- Autoimmune disease with the exceptions specified in the protocol
Show all 10Show fewer
- History of central nervous system(CNS) lymphoma or other CNS disease
- Significant cardiovascular or pulmonary disease
- Hepatitis B or C or human immunodeficiency virus (HIV)
- Pregnant or lactating or intending to become pregnant during the study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites, 5 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
Cabrini hospital
Melbourne, The State of Victoria, 3144
- Recruiting
Alfred hospital
Melbourne, The State of Vitoria, 3004
- Terminated
Peninsula & South Eastern Haematology & Oncology Group
Melbourne, The State of Vitoria, 3199
- Recruiting
One Clinical Research Pty Ltd
Mount Pleasant, Western Australia, 6153
- Recruiting
St Vincent's Hospital/The Kinghorn Cancer Centre
Sydney, New South Wales, 2010
About this study
Official title: A Phase Ⅰ/Ⅱ, 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
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.
- Conditions
- B Cell NHL, CLL
- Being tested
- GB261
- Keywords
- B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB261Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| GB261 | Experimental | 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. Receives: Biological: GB261 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose
Measured: During Cycle 1 (up to 21 days)
Dose Limiting Toxicity
Measured: During Cycle 1 (up to 21 days)
Percentage of participants with adverse events
Measured: From first dosing until 90 days after the last treatment
Objective Response Rate
Measured: Through study completion, an average of 3 years
Secondary outcomes (11)
Cmax
Measured: At predefined intervals up to 106 days
Tmax
Measured: At predefined intervals up to 106 days
Area Under the Curve
Measured: At predefined intervals up to 106 days
t1/2
Measured: At predefined intervals up to 106 days
Clearance
Measured: At predefined intervals up to 106 days
Vz
Measured: At predefined intervals up to 106 days
Anti-Drug Antibody
Measured: At predefined intervals up to 3 years
Progression Free Survival
Measured: Through study completion, an average of 3 years
Duration of Objective Response
Measured: Through study completion, an average of 3 years
Duration of Objective Complete Response
Measured: Through study completion, an average of 3 years
Overall Survival
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start31 Aug 2021
- Primary completion28 Jun 2024 (estimated)
- Study completion28 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell NHLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923048
- Sponsor's protocol ID
- GB261-001
- Status last verified
- Jun 2022
- First submitted
- 4 Jun 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ/Ⅱ, 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
- ClinicalTrials.gov ID
- NCT04923048
- Acronym / sponsor ID
- GB261-001
- Conditions
- B Cell NHL, CLL
- Keywords
- B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 28 Jun 2025 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB261 | Experimental | Biological: GB261Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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
- Adequate hepatic, hematologic, and renal function
Key exclusion criteria (10 listed)
- Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia
- 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
- History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions
- Prior allo-SCT or allogeneic CAR-T
- Prior solid organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB261Drug: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. | Biological | GB261 |
Primary outcome
Maximum Tolerated Dose
Time frame: During Cycle 1 (up to 21 days)
Dose Limiting Toxicity
Time frame: During Cycle 1 (up to 21 days)
Percentage of participants with adverse events
Time frame: From first dosing until 90 days after the last treatment
Objective Response Rate
Time frame: Through study completion, an average of 3 years
11 secondary outcomes
Cmax
Time frame: At predefined intervals up to 106 days
Tmax
Time frame: At predefined intervals up to 106 days
Area Under the Curve
Time frame: At predefined intervals up to 106 days
t1/2
Time frame: At predefined intervals up to 106 days
Clearance
Time frame: At predefined intervals up to 106 days
Vz
Time frame: At predefined intervals up to 106 days
Anti-Drug Antibody
Time frame: At predefined intervals up to 3 years
Progression Free Survival
Time frame: Through study completion, an average of 3 years
Duration of Objective Response
Time frame: Through study completion, an average of 3 years
Duration of Objective Complete Response
Time frame: Through study completion, an average of 3 years
Overall Survival
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GB261 in people with B Cell NHL and CLL, run by Genor Biopharma Co., Ltd. at 6 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Yu, MD (021-60751991, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (time frame: During Cycle 1 (up to 21 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.