NCT04923048

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2021

Longer than P75 for phase_1

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 31, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

May 22, 2023

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

June 4, 2021

Last Update Submit

May 19, 2023

Conditions

B Cell NHLCLL

Keywords

B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

GB261

EXPERIMENTAL

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

Interventions

GB261BIOLOGICAL

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.

GB261

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

St Vincent's Hospital/The Kinghorn Cancer Centre

Sydney, New South Wales, 2010, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Cabrini hospital

Melbourne, The State of Victoria, 3144, Australia

RECRUITING

Alfred hospital

Melbourne, The State of Vitoria, 3004, Australia

RECRUITING

Peninsula & South Eastern Haematology & Oncology Group

Melbourne, The State of Vitoria, 3199, Australia

TERMINATED

One Clinical Research Pty Ltd

Mount Pleasant, Western Australia, 6153, Australia

RECRUITING

Central Study Contacts

Xiao Yu, MD

CONTACT

021-60751991shawn.yu@genorbio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2021

First Posted

June 11, 2021

Study Start

August 31, 2021

Primary Completion

June 28, 2024

Study Completion

June 28, 2025

Last Updated

May 22, 2023

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)