HDM2005 Combination Therapy in Relapsed/Refractory Mantle Cell Lymphoma

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07697339
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len — DRUG
    HDM2005 will be administered in combination with rituximab and lenalidomide.
  • Rituximab plus lenalidomide — DRUG
    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.
  • Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len — DRUG
    HDM2005 will be administered in combination with rituximab and lenalidomide.
  • HDM2005 plus rituximab and lenalidomide — DRUG
    HDM2005 will be administered in combination with rituximab and lenalidomide.

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Jul 10, 2026
Status verified
Jul 2026
Primary completion
Aug 10, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len
    Participants in this Phase Ib cohort will receive HDM2005 1.2 mg/kg in combination with rituximab and lenalidomide during induction treatment.
  • Experimental: Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len
    Participants in this Phase Ib cohort will receive HDM2005 1.4 mg/kg in combination with rituximab and lenalidomide during induction treatment.
  • Experimental: Phase III Active Arm: HDM2005 plus rituximab and lenalidomide
    HDM2005 will be administered in combination with rituximab and lenalidomide.
  • Active Comparator: Phase III Control Arm: Rituximab plus lenalidomide
    Rituximab plus lenalidomide is used as part of the HDM2005 combination regimen as control arm.

Primary Outcome Measure

Phase Ib: Incidence and severity of adverse events [ Time Frame: From the date of first dose until end of treatment, assessed up to 12 months. ]

Central Contacts

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