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

Phase 1

Recruiting

• Conditions: B Cell NHL; CLL
• Interventions: Biological: GB261

• Registration Number: NCT04923048
• Lead Sponsor: Genor Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-04
• Study First Submitted QC: 2021-06-10
• Study First Posted: 2021-06-11
• Study Start: 2021-08-31
• Status Verified: 2022-06
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22
• Primary Completion: 2024-06-28
• Study Completion: 2025-06-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GB261	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.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	During Cycle 1 (up to 21 days)
Maximum Tolerated Dose	During Cycle 1 (up to 21 days)
Objective Response Rate	Through study completion, an average of 3 years
Percentage of participants with adverse events	From first dosing until 90 days after the last treatment

Secondary Outcome Measures

Name	Time	Method
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
t1/2	At predefined intervals up to 106 days
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
Progression Free Survival	Through study completion, an average of 3 years
Duration of Objective Complete Response	Through study completion, an average of 3 years
Duration of Objective Response	Through study completion, an average of 3 years
Overall Survival	Through study completion, an average of 3 years

Trial Locations

Locations (6)

One Clinical Research Pty Ltd; 🇦🇺 Mount Pleasant, Western Australia, Australia

St Vincent's Hospital/The Kinghorn Cancer Centre; 🇦🇺 Sydney, New South Wales, Australia

Cabrini hospital; 🇦🇺 Melbourne, The State Of Victoria, Australia

Alfred hospital; 🇦🇺 Melbourne, The State Of Vitoria, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Peninsula & South Eastern Haematology & Oncology Group; 🇦🇺 Melbourne, The State Of Vitoria, Australia