Mantle Cell LymphomaPhase 1NCT07697339
HDM2005 Combination Therapy in Relapsed/Refractory Mantle Cell Lymphoma
A Phase 1 study testing Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len, Rituximab plus lenalidomide and Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len in people with Mantle Cell Lymphoma, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len, Rituximab plus lenalidomide and Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 1 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part.
- Adequate organ and bone marrow function as defined in the protocol.
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- Estimated life expectancy of more than 3 months.
- Willingness to provide archived or fresh tumor tissue for central pathology review, if available.
- Willingness to follow the study treatment plan, visit schedule, and contraceptive requirements.
- Written informed consent provided before any study-specific procedures.
Who cannot join
- 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.
- Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol.
- History or current evidence of interstitial lung disease, active interstitial lung disease, or radiation pneumonitis requiring steroid treatment.
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- Clinically significant cardiovascular or cerebrovascular disease that may increase study risk.
- Prior allogeneic hematopoietic stem cell transplantation with active or clinically significant graft-versus-host disease, or need for systemic immunosuppressive treatment for graft-versus-host disease.
- Prior solid organ transplantation.
- Other active malignancy or malignancy with a clinically significant risk of recurrence, except for certain adequately treated cancers as defined in the protocol.
- Unresolved clinically significant toxicity from prior anti-cancer therapy.
- Recent anti-cancer therapy, investigational treatment, major surgery, or radiotherapy within the protocol-defined washout period.
- Known allergy or contraindication to any study treatment or its components.
- Active autoimmune disease or immunodeficiency requiring systemic treatment, except for protocol-defined stable conditions.
- Pregnancy, breastfeeding, or planned pregnancy during the study.
- Any medical, psychiatric, laboratory, or social condition that, in the investigator's judgment, may interfere with study participation, study assessments, or participant safety.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase Ib/III Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed/Refractory Mantle Cell Lymphoma
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.
Read more
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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len, Rituximab plus lenalidomide, Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len, HDM2005 plus rituximab and lenalidomide
- Keywords
- ROR1-ADC, Mantle cell lymphoma
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-LenDrug
Also called HDM2005 + R-Len
HDM2005 will be administered in combination with rituximab and lenalidomide.
Rituximab plus lenalidomideDrug
Also called R-Len
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-LenDrug
Also called HDM2005 + R-Len
HDM2005 will be administered in combination with rituximab and lenalidomide.
HDM2005 plus rituximab and lenalidomideDrug
Also called HDM2005 + R-Len
HDM2005 will be administered in combination with rituximab and lenalidomide.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len | Experimental | Participants in this Phase Ib cohort will receive HDM2005 1.2 mg/kg in combination with rituximab and lenalidomide during induction treatment. Receives: Drug: Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len |
| Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len | Experimental | Participants in this Phase Ib cohort will receive HDM2005 1.4 mg/kg in combination with rituximab and lenalidomide during induction treatment. Receives: Drug: Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len |
| Phase III Active Arm: HDM2005 plus rituximab and lenalidomide | Experimental | HDM2005 will be administered in combination with rituximab and lenalidomide. Receives: Drug: HDM2005 plus rituximab and lenalidomide |
| Phase III Control Arm: Rituximab plus lenalidomide | Active comparator | Rituximab plus lenalidomide is used as part of the HDM2005 combination regimen as control arm. Receives: Drug: Rituximab plus lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of first dose until end of treatment, assessed up to 12 months.
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.
Measured: From the first dose of study treatment until disease progression, or other protocol re-specified reasesons, whichever occurs first, assessed up to 11 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Aug 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697339
- Sponsor's protocol ID
- HDM2005-301
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Clinical Trial to Evaluate HDM2005 in Combination Therapy for Patients With Relapsed/Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07697339
- Acronym / sponsor ID
- HDM2005-301
- Conditions
- Mantle Cell Lymphoma
- Keywords
- ROR1-ADC, Mantle cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Aug 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len | Experimental | Drug: Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-LenParticipants in this Phase Ib cohort will receive HDM2005 1.2 mg/kg in combination with rituximab and lenalidomide during induction treatment. |
| Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len | Experimental | Drug: Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-LenParticipants in this Phase Ib cohort will receive HDM2005 1.4 mg/kg in combination with rituximab and lenalidomide during induction treatment. |
| Phase III Active Arm: HDM2005 plus rituximab and lenalidomide | Experimental | Drug: HDM2005 plus rituximab and lenalidomideHDM2005 will be administered in combination with rituximab and lenalidomide. |
| Phase III Control Arm: Rituximab plus lenalidomide | Active comparator | Drug: Rituximab plus lenalidomideRituximab plus lenalidomide is used as part of the HDM2005 combination regimen as control arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part.
Key exclusion criteria (16 listed)
- 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.
- Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-LenAlso: HDM2005 + R-LenHDM2005 will be administered in combination with rituximab and lenalidomide. | Drug | Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len |
| Rituximab plus lenalidomideAlso: R-LenRituximab 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 III Control Arm: Rituximab plus lenalidomide |
| Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-LenAlso: HDM2005 + R-LenHDM2005 will be administered in combination with rituximab and lenalidomide. | Drug | Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len |
| HDM2005 plus rituximab and lenalidomideAlso: HDM2005 + R-LenHDM2005 will be administered in combination with rituximab and lenalidomide. | Drug | Phase III Active Arm: HDM2005 plus rituximab and lenalidomide |
Primary outcome
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.
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
Time frame: From the first dose of study treatment until disease progression, or other protocol re-specified reasesons, whichever occurs first, assessed up to 11 months.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Phase Ib Cohort 1: HDM2005 1.2 mg/kg + R-Len, Rituximab plus lenalidomide and Phase Ib Cohort 2: HDM2005 1.4 mg/kg + R-Len in people with Mantle Cell Lymphoma, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruichao Zeng, PhD (+86-571-89903388 ext. +86-571-899033, zengruichao@eastchinapharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.