The purpose of this clinical trial it to test the safety and tolerability of the study drugs mosunetuzumab in combination with pirtobrutinib in patients with relapsed or refractory Waldenstrom's Macroglobulinemia.
Subjects aged ≥ 18 years with documented diagnosis of WM with the definition of measurable disease
Subjects who are able to comply with the study protocol.
Subjects with relapsed or refractory WM who have received at least one prior line of therapy.
Must have received prior treatment with covalent BTK inhibitor or have declined such treatment.
History of transformation of indolent disease to DLBCL
Active or history of CNS lymphoma or leptomeningeal infiltration
Prior treatment with a non-covalent BTK inhibitor
Prior treatment with CD20-directed bispecific antibody therapy
Sequential
Pirtobrutinib
Drug200 mg daily
Mosunetuzumab
DrugAdministered subcutaneously on day one of applicable cycles.
The recommended phase 2 dose (RP2D) which will be determined based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
To determine the safety and tolerability of mosunetuzumab in combination with pirtobrutinib.
Best very good partial response (VGPR) or better per the modified IWWM6 criteria.1
To determine the efficacy of the combination of mosunetuzumab and pirtobrutinib.
Best response rates including partial response (PR), Best very good partial response (VGPR), complete response (CR), major response (PR+VGPR+CR) and overall response (minor response + major response).
To evaluate the best response rates of mosunetuzumab + pirtobrutinib.
Best very good partial response (VGPR)/partial response (PR)/minor response conversion rates from Cycle 8 to 18 (dosing strategy 1(DS1)), and Cycle 9 to 19 (dosing strategy 2(DS2)), as applicable.
To evaluate the conversion rate from Cycle 8 to 18 (DS1) and Cycle 9 to 19 (DS2), as applicable.
Duration of response (DoR), defined as the interval of time from the date of initial documented response (minor response or better per modified IWWM6 criteria) to the time of relapse or death from any cause.
To evaluate the DoRof the study population.
Progression free survival (PFS) as defined as the time from study therapy initiation to the time documented disease progression (as assessed by modified IWWM6 criteria) or death from any cause.
To assess median and 2-year PFS.
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This trial is not recruiting at the moment. You can still explore other options:
