A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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B Cell NHL, CLL

Intervention / Treatment
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* Biological: GB261


Participation Criteria
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Eligibility Criteria
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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 Adequate hepatic, hematologic, and renal function Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GB261<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3