Zanubrutinib (Btk inhibitor) and tisleblizumab (anti-PD-1) in relapsed/refractory B-cell malignancies

Zanubrutinib (Btk inhibitor) and tisleblizumab (PD-1 inhibitor) in relapsed/refractory B-cell malignancies

A Phase 1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Assess Safety, Tolerability and Antitumor Activities of the Combination of BGB-3111 with BGB-A317 in Subjects with B-Cell Lymphoid Malignancies

Disease:

Lymphoma -> small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), hairy cell leukaemia (HCL), transformed indolent lymphoma to diffuse large B-cell lymphoma, central nervous system lymphoma

Summary:

Non-Hodgkin lymphomas are cancers of white blood cells that can be divided into indolent (slow growing) and aggressive (fast growing), though they share common pathways that can be targeted by anti-cancer drugs.

This trial is for patients who have non-Hodgkin lymphoma which has returned after treatment. Patients will receive BGB-3111 (zanubrutinib) and BGB-A317 (tisleblizumab). Zanubrutinib is taken by mouth, and works by targeting an important part of the cancer cell called Bruton’s tyrosine kinase (Btk), which causes the cells to die. Tisleblizumab is give through an intravenous drip and works by ‘revealing’ the cancer to the immune system to be killed.

The aim of the trial is to see whether the combination of medications is effective and safe in patients with non-Hodgkin lymphoma.

Eligibility:

Include, but not limited to, the following:

- Patients must be aged 18 or over
- A B-cell non-Hodgkin lymphoma that has continued to grow (refractory) or returned (relapsed) after at least one line of treatment
- No previous use of these types of medications
- No other active cancers (other than some cancers cured with minor operations like skin cancer)
- No other major health problems

Contact person:

Louise Hay

Email louise.hay@health.wa.gov.au

Phone 6457 7600

Principal Investigator:

Dr Gavin Cull

08 6457 7600

Sponsor:

BeiGene Australia

Phase:

Ib

Protocol Number:

BGB-3111/BGB-A317 Study 001

Trial Registration Number:

NCT02795182

Clinical Trials.gov

ANZ Clinical Trial Registry