Could a pre-treatment boost t-cell power against myeloma?
NCT ID NCT07581704
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.
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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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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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
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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: 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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University of Iowa Health Care
RECRUITINGIowa City, Iowa, 52242, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Bispecific antibody combo aims to deepen myeloma responses
- Can a stronger drug cocktail give older myeloma patients a better start?
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas