Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07697339
PHASE1

HDM2005 Combination Therapy in Relapsed/Refractory Mantle Cell Lymphoma

Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase Ib/III Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed/Refractory Mantle Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-10

Completion Date

2028-12-01

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

DRUG

Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len

HDM2005 will be administered in combination with rituximab and lenalidomide.

DRUG

Rituximab plus lenalidomide

Rituximab plus lenalidomide is used as part of the HDM2005 combination regimen and may also be selected as comparator treatment in the Phase III part.

DRUG

Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len

HDM2005 will be administered in combination with rituximab and lenalidomide.

DRUG

HDM2005 plus rituximab and lenalidomide

HDM2005 will be administered in combination with rituximab and lenalidomide.