New drug combo aims to outsmart Hard-to-Treat lymphoma
NCT ID NCT07697339
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This clinical trial is testing whether adding an experimental drug called HDM2005 to a standard treatment (rituximab and lenalidomide) can help people with mantle cell lymphoma whose cancer has returned or not responded to previous therapies. The study involves about 40 adults and has two parts: first, to find the safest dose of HDM2005, and then to compare the combination against other standard treatments. The main goals are to see if the new combination shrinks tumors and delays cancer growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HDM2005 (a targeted therapy) combined with rituximab and lenalidomide
- What this could lead to
- If successful, this combination could offer a new treatment option for patients with mantle cell lymphoma that has returned or stopped responding to prior therapies.
- What could go wrong
- This is an early-phase study with a small number of participants, so the benefits are uncertain. Side effects from the drug combination may occur, and the treatment may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Adult participants aged 18 years or older. 2. Histologically confirmed mantle cell lymphoma with cyclin D1 overexpression or documented t(11;14). 3. 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. 4. At least one measurable lesion according to the 2014 Lugano response criteria. 5. Eastern Cooperative Oncology Group performance status of 0 to 1 for the Phase Ib part, or 0 to 2 for the Phase III part. 6. Adequate organ and bone marrow function as defined in the protocol. 7. Estimated life expectancy of more than 3 months. 8. Willingness to provide archived or fresh tumor tissue for central pathology review, if available. 9. Willingness to follow the study treatment plan, visit schedule, and contraceptive requirements. 10. Written informed consent provided before any study-specific procedures. Exclusion Criteria: 1. Leukemic non-nodal mantle cell lymphoma. 2. Known central nervous system involvement by lymphoma. 3. Prior treatment with a ROR1-targeted therapy. 4. Active or uncontrolled infection requiring systemic treatment. 5. Active infectious disease, including uncontrolled hepatitis B, active hepatitis C, human immunodeficiency virus infection, or active syphilis, as defined in the protocol. 6. History or current evidence of interstitial lung disease, active interstitial lung disease, or radiation pneumonitis requiring steroid treatment. 7. Clinically significant cardiovascular or cerebrovascular disease that may increase study risk. 8. 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. 9. Prior solid organ transplantation. 10. Other active malignancy or malignancy with a clinically significant risk of recurrence, except for certain adequately treated cancers as defined in the protocol. 11. Unresolved clinically significant toxicity from prior anti-cancer therapy. 12. Recent anti-cancer therapy, investigational treatment, major surgery, or radiotherapy within the protocol-defined washout period. 13. Known allergy or contraindication to any study treatment or its components. 14. Active autoimmune disease or immunodeficiency requiring systemic treatment, except for protocol-defined stable conditions. 15. Pregnancy, breastfeeding, or planned pregnancy during the study. 16. Any medical, psychiatric, laboratory, or social condition that, in the investigator's judgment, may interfere with study participation, study assessments, or participant safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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