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

CLL Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04923048
• Other study ID #: GB261-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 31, 2021
• Est. completion date: June 28, 2025

Study information

• Verified date: June 2022
• Source: Genor Biopharma Co., Ltd.
• Contact: Xiao Yu, MD
• Phone: 021-60751991
• Email: shawn.yu[@]genorbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: June 28, 2025
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CLL

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Alfred hospital	Melbourne	The State Of Vitoria
Australia	Cabrini hospital	Melbourne	The State Of Victoria
Australia	Peninsula & South Eastern Haematology & Oncology Group	Melbourne	The State Of Vitoria
Australia	One Clinical Research Pty Ltd	Mount Pleasant	Western Australia
Australia	St Vincent's Hospital/The Kinghorn Cancer Centre	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Genor Biopharma Co., Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		During Cycle 1 (up to 21 days)
Primary	Dose Limiting Toxicity		During Cycle 1 (up to 21 days)
Primary	Percentage of participants with adverse events		From first dosing until 90 days after the last treatment
Primary	Objective Response Rate		Through study completion, an average of 3 years
Secondary	Cmax		At predefined intervals up to 106 days
Secondary	Tmax		At predefined intervals up to 106 days
Secondary	Area Under the Curve		At predefined intervals up to 106 days
Secondary	t1/2		At predefined intervals up to 106 days
Secondary	Clearance		At predefined intervals up to 106 days
Secondary	Vz		At predefined intervals up to 106 days
Secondary	Anti-Drug Antibody		At predefined intervals up to 3 years
Secondary	Progression Free Survival		Through study completion, an average of 3 years
Secondary	Duration of Objective Response		Through study completion, an average of 3 years
Secondary	Duration of Objective Complete Response		Through study completion, an average of 3 years
Secondary	Overall Survival		Through study completion, an average of 3 years