New drug combo aims to outsmart Hard-to-Treat lymphoma

NCT ID NCT07697339

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

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  1. 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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