B Cell NHL, CLL
Conditions
Keywords
B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3
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.
Interventions
BIOLOGICALGB261
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.
Sponsors
Genor Biopharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Cmax | At predefined intervals up to 106 days |
| 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 |
| Progression Free Survival | Through study completion, an average of 3 years |
| 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 |
Countries
Australia
Contacts
Primary ContactXiao Yu, MD
Outcome results
None listed