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Could a pre-treatment boost t-cell power against myeloma?

NCT ID NCT07581704

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether giving sirolimus before standard bispecific antibody therapy can improve T-cell function and treatment response in people with multiple myeloma. About 10 participants will receive sirolimus first, then the antibody treatment. The main goals are to check safety and measure changes in immune cells, with results helping to design larger future trials.

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 10 people

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

Started

Jun 2026

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: To be eligible to participate in this study, an individual must meet all of the following criteria: * Willingness and ability to provide signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Aged 18 years of older. * Diagnosis with multiple myeloma, per IMWG Consensus Criteria.20 * Planned for treatment with teclistamab, or talquetamab per standard of care, label indications.15 * Prior exposure to any of the following types of T-cell engaging therapies. 1. Anti-BCMA x CD3 bispecific antibody (for example: teclistamab, elranatamab) 2. Anti-GPRC5d x CD3 bispecific antibody (for example: talquetamab) 3. Anti-GPRC5d x CD3 x CD38 trispecific antibody 4. Anti-BCMA x CD3 x CD38 trispecific antibody 5. Anti-BCMA x CD3 x GPRC5d trispecific antibody 6. Anti-BCMA chimeric antigen T-cell (for example: idecabtagene vicleucel, ciltacabtagene autoleucel) 7. Anti-FcRL5 x CD3 bispecific antibody * Required clinical laboratory values during screening phase Hematologic Parameters Hemoglobin ≥7.0 g/dL; Platelets ≥25 x 109/L; Absolute Lymphocyte Count ≥0.2 x 109/L Chemistries AST/ALT \< 5 x the ULN; Total Bilirubin \< 3 x the ULN * Ability to take oral medication and be willing to adhere to the sirolimus pre-conditioning regimen. * ECOG performance status of 0, 1, or 2 (KPS of \>50). * For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner per section5.3. * Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Participants whose multiple myeloma is progressing at a rapid pace requiring immediate anti-myeloma therapy per assessment by the principal investigator or enrolling investigator are excluded. * Excluded concomitant medication exposures: * Exposure to corticosteroids within 1 week of treatment start * Exposure to calcineurin inhibitor or mTOR inhibitors (tacrolimus, everolimus, temsirolimus, sirolimus) * Immunomodulatory monoclonal antibodies targeting tumor necrosis factor alpha (e.g. infliximab), interleukin 6 (e.g. siltuximab), * Janus kinase inhibitors (e.g. ruxolitinib) * Any other investigational drug within 28 days * History of allogeneic hematopoietic cell transplantation. * Excluded concurrent medical conditions: * Active uncontrolled infection within 7 days prior to treatment start * Uncontrolled thrombotic event within 3 months of treatment start * Acute myocardial infarction or acute coronary syndrome within 6 months of start of treatment * Uncontrolled inflammatory bowel disease * Active hepatitis B virus, hepatitis C virus, or Human Immunodeficiency Virus infection * Uncontrolled rheumatologic conditions * Use of ACE-inhibitor therapy within 1 week of treatment start * Patients found to be taking ace-inhibitor therapy during screening can be included if the ace-inhibitor is substituted for an angiotensin receptor blocking agent. (https://drug-interactions.medicine.iu.edu/main-table) * CYP3A4/p-gp inhibitors and inducers for 7 days prior to sirolimus doses and 7 days after sirolimus doses(see appendix A for list) * Any other current active malignancy or history of metastatic malignancy that has the potential to interfere with the safety or efficacy assessment of the investigational intervention * Pregnancy or lactation. * Known allergic reactions to study agent (sirolimus).

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University of Iowa Health Care

    RECRUITING

    Iowa City, Iowa, 52242, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.