Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
Trial participants will receive GB261, a bi-specific antibody that binds to two different types of antigens (CD3 and CD20), intravenously as a single agent on Day 1, 8 and 15 of Cycle 1 and 2, and on Day 1 of each 21-day Cycle after that.
Conditions
This trial is treating people with B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukaemia
Eligibility
Inclusion
- 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
Exclusion
- 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
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Tigermed Australia
Scientific 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
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