Clinical trial NCT04923048: A Safety, Tolerability, Pharmacokinetics and Efficacy Study of GB261 in B-Cell NHL and CLL.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: B Cell NHL
CLL
Keywords: B cell NHL, Phase 1/2,GB261,bispecific antibody,CD20/CD3
Lead sponsor: Genor Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-11
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: During Cycle 1 (up to 21 days)
measure: Dose Limiting Toxicity
timeFrame: During Cycle 1 (up to 21 days)
measure: Percentage of participants with adverse events
timeFrame: From first dosing until 90 days after the last treatment
measure: Objective Response Rate
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Cmax
timeFrame: At predefined intervals up to 106 days
measure: Tmax
timeFrame: At predefined intervals up to 106 days
measure: Area Under the Curve
timeFrame: At predefined intervals up to 106 days
measure: t1/2
timeFrame: At predefined intervals up to 106 days
measure: Clearance
timeFrame: At predefined intervals up to 106 days
measure: Vz
timeFrame: At predefined intervals up to 106 days
measure: Anti-Drug Antibody
timeFrame: At predefined intervals up to 3 years
measure: Progression Free Survival
timeFrame: Through study completion, an average of 3 years
measure: Duration of Objective Response
timeFrame: Through study completion, an average of 3 years
measure: Duration of Objective Complete Response
timeFrame: Through study completion, an average of 3 years
measure: Overall Survival
timeFrame: Through study completion, an average of 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital/The Kinghorn Cancer Centre
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Cabrini hospital
state: The State Of Victoria
city: Melbourne
country: Australia
facility: Alfred hospital
state: The State Of Vitoria
city: Melbourne
country: Australia
facility: Peninsula & South Eastern Haematology & Oncology Group
state: The State Of Vitoria
city: Mount Pleasant
country: Australia
facility: One Clinical Research Pty Ltd
state: Western Australia
Study officials:
References: