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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.

Tracking Information
First Submitted Date  ICMJE June 4, 2021
First Posted Date  ICMJE June 11, 2021
Last Update Posted Date August 5, 2022
Actual Study Start Date  ICMJE August 31, 2021
Estimated Primary Completion Date June 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2022)
  • Maximum Tolerated Dose [ Time Frame: During Cycle 1 (up to 21 days) ]
  • Dose Limiting Toxicity [ Time Frame: During Cycle 1 (up to 21 days) ]
  • Percentage of participants with adverse events [ Time Frame: From first dosing until 90 days after the last treatment ]
  • Objective Response Rate [ Time Frame: Through study completion, an average of 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Maximum Tolerated Dose [ Time Frame: During Cycle 1 (up to 21 days) ]
    To determine the maximum Tolerated Dose (MTD) of GB261
  • Dose Limiting Toxicity [ Time Frame: During Cycle 1 (up to 21 days) ]
    To determine the frequency and nature of Dose Limiting Toxicity (DLT) of GB261
  • Percentage of participants with adverse events [ Time Frame: From first dosing until 90 days after the last treatment ]
    To determine the percentage of participants with adverse events
  • Objective Response Rate [ Time Frame: Through study completion, an average of 3 years ]
    To determine the Objective Response Rate (ORR) of GB261
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2022)
  • Cmax [ Time Frame: At predefined intervals up to 106 days ]
  • Tmax [ Time Frame: At predefined intervals up to 106 days ]
  • Area Under the Curve [ Time Frame: At predefined intervals up to 106 days ]
  • t1/2 [ Time Frame: At predefined intervals up to 106 days ]
  • Clearance [ Time Frame: At predefined intervals up to 106 days ]
  • Vz [ Time Frame: At predefined intervals up to 106 days ]
  • Anti-Drug Antibody [ Time Frame: At predefined intervals up to 3 years ]
  • Progression Free Survival [ Time Frame: Through study completion, an average of 3 years ]
  • Duration of Objective Response [ Time Frame: Through study completion, an average of 3 years ]
  • Duration of Objective Complete Response [ Time Frame: Through study completion, an average of 3 years ]
  • Overall Survival [ Time Frame: Through study completion, an average of 3 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2021)
  • Cmax [ Time Frame: At predefined intervals up to 106 days ]
    To determine the Cmax of GB261
  • Tmax [ Time Frame: At predefined intervals up to 106 days ]
    To determine the Tmax of GB261
  • Area Under the Curve [ Time Frame: At predefined intervals up to 106 days ]
    To determine the Area Under the Curve (AUC) of GB261
  • t1/2 [ Time Frame: At predefined intervals up to 106 days ]
    To determine the t1/2 of GB261
  • Clearance [ Time Frame: At predefined intervals up to 106 days ]
    To determine the Clearance (CL) of GB261
  • Vz [ Time Frame: At predefined intervals up to 106 days ]
    To determine the Vz of GB261
  • Anti-Drug Antibody [ Time Frame: At predefined intervals up to 3 years ]
    To determine Anti-Drug Antibody (ADA) of GB261
  • Progression Free Survival [ Time Frame: Through study completion, an average of 3 years ]
    To determine the progression free survival (PFS)
  • Duration of Objective Response [ Time Frame: Through study completion, an average of 3 years ]
    To determine the Duration of Objective Response (DOR)
  • Duration of Objective Complete Response [ Time Frame: Through study completion, an average of 3 years ]
    To determine the Duration of Objective Complete Response (DOCR)
  • Overall Survival [ Time Frame: Through study completion, an average of 3 years ]
    To determine the Overall Survival (OS)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • B Cell NHL
  • CLL
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Biological: GB261
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2021)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2025
Estimated Primary Completion Date June 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xiao Yu, MD 021-60751991 shawn.yu@genorbio.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04923048
Other Study ID Numbers  ICMJE GB261-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Genor Biopharma Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Genor Biopharma Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genor Biopharma Co., Ltd.
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP