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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
460
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.
St Vincent's Hospital/The Kinghorn Cancer Centre
Sydney, New South Wales, Australia
RECRUITINGRoyal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGCabrini hospital
Melbourne, The State of Victoria, Australia
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
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
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Alfred hospital
Melbourne, The State of Vitoria, Australia
RECRUITINGPeninsula & South Eastern Haematology & Oncology Group
Melbourne, The State of Vitoria, Australia
TERMINATEDOne Clinical Research Pty Ltd
Mount Pleasant, Western Australia, Australia
RECRUITINGDuration 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