Tests sirolimus before bispecific antibody treatment in multiple myeloma
Tests sirolimus followed by bispecific antibody therapy in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
Key facts
- Where
- Iowa City, United StatesSee the site
- Phase
- Phase 1
Where in United States
- University of Iowa Health CareIowa City, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Christopher Strouse
- Trial code
- NCT07581704
- Record updated
- 4 June 2026
- Original description
This is a single center, single arm Phase Ib study with expansion cohort designed to establish the safety and physiologic effects of sirolimus pre-conditioning followed by T-cell engaging bispecific antibody therapy.Read full original descriptionShow less
Impact of Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
This is a single center, single arm Phase Ib study with expansion cohort designed to establish the safety and physiologic effects of sirolimus pre-conditioning followed by T-cell engaging bispecific antibody therapy.
Inclusion: 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; Anti-BCMA x CD3 bispecific antibody (for example: teclistamab, elranatamab); Anti-GPRC5d x CD3 bispecific antibody (for example: talquetamab); Anti-GPRC5d x CD3 x CD38 trispecific antibody; Anti-BCMA x CD3 x CD38 trispecific antibody; Anti-BCMA x CD3 x GPRC5d trispecific antibody; Anti-BCMA chimeric antigen T-cell (for example: idecabtagene vicleucel, ciltacabtagene autoleucel); 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: 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; 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; History of allogeneic hematopoietic cell transplantation; Known allergic reactions to study agent (sirolimus); An individual who meets any of the following criteria will be excluded from participation in this study:; Pregnancy or lactation.