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Closed (no longer recruiting)Last updated: 20 February 2024

This trial is trying to understand how safe and well tolerated a new form of targeted therapy is, in people with B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukaemia that has got worse or not responded to previous treatmentA 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 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 patients with B-Cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukaemia.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I/II

More information

Trial Identifiers

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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

Eligibility

Inclusion

  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

  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

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.
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Clinical trials have complex eligibility criteria.

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