This is a Phase Ib/III, multicenter, open-label clinical study of HDM2005 in combination with rituximab and lenalidomide in adult patients with relapsed or refractory mantle cell lymphoma.
Mantle cell lymphoma is a type of non-Hodgkin lymphoma. Some patients have disease that comes back after treatment or does not respond well to available treatments. This study is designed to evaluate whether adding HDM2005 to rituximab and lenalidomide may provide clinical benefit for patients with relapsed or refractory mantle cell lymphoma who have previously received an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor.
The study includes two parts. In the Phase Ib part, participants will receive HDM2005 in combination with rituximab and lenalidomide. The main goals of this part are to evaluate the safety and tolerability of the combination, assess preliminary anti-tumor activity, and determine the recommended dose of HDM2005 for the Phase III part.
In the Phase III part, eligible participants will be randomly assigned to receive either HDM2005 at the recommended Phase III dose in combination with rituximab and lenalidomide, or the investigator's choice of comparator treatment with rituximab plus lenalidomide or bendamustine plus rituximab. The main goals of the Phase III part are to compare the anti-tumor activity and clinical benefit of the HDM2005 combination with the comparator treatments. The main measures of efficacy include objective response rate and progression-free survival, assessed according to the 2014 Lugano response criteria. The study will also evaluate safety, pharmacokinetics, immunogenicity, overall survival, duration of response, and other measures of anti-tumor activity.
Adult participants aged 18 years or older.
Histologically confirmed mantle cell lymphoma with cyclin D1 overexpression or documented t(11;14).
Relapsed or refractory mantle cell lymphoma after prior treatment with an anti-CD20 antibody-containing regimen and at least one Bruton's tyrosine kinase inhibitor, unless a BTK inhibitor was not suitable or was not tolerated.
At least one measurable lesion according to the 2014 Lugano response criteria.
Leukemic non-nodal mantle cell lymphoma.
Known central nervous system involvement by lymphoma.
Prior treatment with a ROR1-targeted therapy.
Active or uncontrolled infection requiring systemic treatment.
Parallel
Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len
DrugHDM2005 will be administered in combination with rituximab and lenalidomide.
Rituximab plus lenalidomide
DrugRituximab plus lenalidomide is used as part of the HDM2005 combination regimen and may also be selected as comparator treatment in the Phase III part.
Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len
DrugHDM2005 will be administered in combination with rituximab and lenalidomide.
HDM2005 plus rituximab and lenalidomide
DrugHDM2005 will be administered in combination with rituximab and lenalidomide.
Phase Ib: Incidence and severity of adverse events
Incidence and severity of adverse events, serious adverse events, and adverse events of special interest will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. Dose interruptions, dose modifications, laboratory test results, vital signs, and other safety assessments will also be evaluated.
Phase Ib: Objective response rate assessed by investigator
Objective response rate is defined as the proportion of participants who achieve complete response or partial response as assessed by the investigator according to the 2014 Lugano response criteria.
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