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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04923048
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Genor Biopharma Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
B Cell NHL CLL Biological: GB261 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 31, 2021
Estimated Primary Completion Date : June 28, 2024
Estimated Study Completion Date : June 28, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose [ Time Frame: During Cycle 1 (up to 21 days) ]
  2. Dose Limiting Toxicity [ Time Frame: During Cycle 1 (up to 21 days) ]
  3. Percentage of participants with adverse events [ Time Frame: From first dosing until 90 days after the last treatment ]
  4. Objective Response Rate [ Time Frame: Through study completion, an average of 3 years ]

Secondary Outcome Measures :
  1. Cmax [ Time Frame: At predefined intervals up to 106 days ]
  2. Tmax [ Time Frame: At predefined intervals up to 106 days ]
  3. Area Under the Curve [ Time Frame: At predefined intervals up to 106 days ]
  4. t1/2 [ Time Frame: At predefined intervals up to 106 days ]
  5. Clearance [ Time Frame: At predefined intervals up to 106 days ]
  6. Vz [ Time Frame: At predefined intervals up to 106 days ]
  7. Anti-Drug Antibody [ Time Frame: At predefined intervals up to 3 years ]
  8. Progression Free Survival [ Time Frame: Through study completion, an average of 3 years ]
  9. Duration of Objective Response [ Time Frame: Through study completion, an average of 3 years ]
  10. Duration of Objective Complete Response [ Time Frame: Through study completion, an average of 3 years ]
  11. Overall Survival [ Time Frame: Through study completion, an average of 3 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04923048


Contacts
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Contact: Xiao Yu, MD 021-60751991 shawn.yu@genorbio.com

Locations
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Australia, New South Wales
St Vincent's Hospital/The Kinghorn Cancer Centre Recruiting
Sydney, New South Wales, Australia, 2010
Australia, The State Of Victoria
Cabrini hospital Recruiting
Melbourne, The State Of Victoria, Australia, 3144
Peninsula & South Eastern Haematology & Oncology Group Recruiting
Melbourne, The State Of Victoria, Australia, 3199
Australia, Western Australia
One Clinical Research Pty Ltd Recruiting
Mount Pleasant, Western Australia, Australia, 6153
Sponsors and Collaborators
Genor Biopharma Co., Ltd.
More Information
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Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04923048    
Other Study ID Numbers: GB261-001
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genor Biopharma Co., Ltd.:
B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3