Trials Sponsors Conditions Drugs Pricing

Conditions

B Cell NHL CLL

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

Genor Biopharma Co., Ltd.
Industrylead

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

Central Study Contacts

Xiao Yu, MD

CONTACT

021-60751991 shawn.yu@genorbio.com

Study Design

Study Type: interventional
Phase: phase 1 2
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

Actual (reported)

Primary Completion

June 28, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (11)

Study Arms (1)

GB261

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (11)

Study Arms (1)

GB261

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (6)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations