A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Biological: 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.
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose [During Cycle 1 (up to 21 days)]
- Dose Limiting Toxicity [During Cycle 1 (up to 21 days)]
- Percentage of participants with adverse events [From first dosing until 90 days after the last treatment]
- Objective Response Rate [Through study completion, an average of 3 years]
Secondary Outcome Measures
- Cmax [At predefined intervals up to 106 days]
- Tmax [At predefined intervals up to 106 days]
- Area Under the Curve [At predefined intervals up to 106 days]
- t1/2 [At predefined intervals up to 106 days]
- Clearance [At predefined intervals up to 106 days]
- Vz [At predefined intervals up to 106 days]
- Anti-Drug Antibody [At predefined intervals up to 3 years]
- Progression Free Survival [Through study completion, an average of 3 years]
- Duration of Objective Response [Through study completion, an average of 3 years]
- Duration of Objective Complete Response [Through study completion, an average of 3 years]
- Overall Survival [Through study completion, an average of 3 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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Adequate hepatic, hematologic, and renal function
Exclusion Criteria:
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Burkitt lymphoma, lymphoplasmacytic lymphoma or B lymphoblastic leukemia
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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
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History of auto-SCT or CAR-T therapy in the past 180 days and/or with any of protocol specified conditions
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Prior allo-SCT or allogeneic CAR-T
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Prior solid organ transplantation
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Autoimmune disease with the exceptions specified in the protocol
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History of central nervous system(CNS) lymphoma or other CNS disease
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Significant cardiovascular or pulmonary disease
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Hepatitis B or C or human immunodeficiency virus (HIV)
-
Pregnant or lactating or intending to become pregnant during the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St Vincent's Hospital/The Kinghorn Cancer Centre | Sydney | New South Wales | Australia | 2010 |
| 2 | Cabrini hospital | Melbourne | The State Of Victoria | Australia | 3144 |
| 3 | Peninsula & South Eastern Haematology & Oncology Group | Melbourne | The State Of Victoria | Australia | 3199 |
| 4 | One Clinical Research Pty Ltd | Mount Pleasant | Western Australia | Australia | 6153 |
Sponsors and Collaborators
- Genor Biopharma Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GB261-001