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

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

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 Overview

• Status: Recruiting
• Conditions: CLL; B Cell NHL
• Intervention / Treatment: Biological: GB261

• Study Type: Interventional
• Enrollment (Anticipated): 460
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Xiao Yu, MD; Phone Number: 021-60751991; Email: shawn.yu@genorbio.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • St Vincent's Hospital/The Kinghorn Cancer Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
  • The State Of Victoria
    • Melbourne, The State Of Victoria, Australia, 3144
      • Recruiting
      • Cabrini Hospital
  • The State Of Vitoria
    • Melbourne, The State Of Vitoria, Australia, 3199
      • Terminated
      • Peninsula & South Eastern Haematology & Oncology Group
    • Melbourne, The State Of Vitoria, Australia, 3004
      • Recruiting
      • Alfred Hospital
  • Western Australia
    • Mount Pleasant, Western Australia, Australia, 6153
      • Recruiting
      • One Clinical Research PTY LTD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Genor Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Anticipated): June 28, 2024
• Study Completion (Anticipated): June 28, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3
• Other Study ID Numbers: GB261-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No