Multiple MyelomaPhase 1NCT07581704
Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
A Phase 1 study testing Sirolimus, Teclistamab and Talquetamb in people with Multiple Myeloma, run by Christopher Strouse at 1 site in United States.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Sirolimus, Teclistamab and Talquetamb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 1 Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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),
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Christopher Strouse, MD, 319-356-0489, christopher-strouse@uiowa.edu
Christopher Strouse, MD, (319) 356-0489, christopher-strouse@uiowa.edu
About this study
Official title: 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.
Read the detailed description
This is a Phase Ib trial with expansion cohort to assess the safety and estimate the preliminary efficacy of sirolimus pre-conditioning prior to treatment with a T-cell engaging bispecific antibody in patients with relapsed / refractory multiple myeloma previously exposed to T-cell engager therapy. Following Phase Ib, the study will enroll an expansion cohort to test the hypothesis that sirolimus pre-conditioning will result in an increase in the Teffector: Texhausted -cell ratio.
- Conditions
- Multiple Myeloma
- Being tested
- Sirolimus, Teclistamab, Talquetamb
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SirolimusDrug
Also called Rapamycin
Sirolimus is an immunosuppressant drug. Sirolimus binds to FK binding protein 12 and inhibits mTOR. This then suppresses T-cell proliferation and inhibits progression from G1 to S phase of the cell cycle.
TeclistamabBiological
Also called Tecvayli
Teclistamab is a bispecific antibody that binds the CD3 receptor on T-cells and the B-cell maturation antigen on multiple myeloma cells and healthy B-lineage cells.
TalquetambBiological
Also called Talvey
Talquetamab is a bispecific antibody that binds the CD3 receptor on T-cells and the GPRC5d receptor on multiple myeloma cells.
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus in combination with teclistamab or talquetamab | Experimental | This study is designed to test changes in immune cell populations of patients with multiple myeloma exposed to short pre-conditioning with sirolimus prior to teclistamab or talquetamab. Safety of the combination will also be assessed. Receives: Drug: Sirolimus; Biological: Teclistamab; Biological: Talquetamb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
The incidence of treatment-emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on NCI CTCAE v5.0) grades), and relation to study treatment. The most severe grade per participant will be reported. Adverse events leading to premature discontinuation from the study intervention and serious treatment-emergent adverse events will be presented in tabular form.
Measured: From treatment initiation through 30 days post last dose of study treatment
Expansion Cohort: Participants change in the Teffector: Texhausted cell ratio
Testing the null hypothesis H0: ΔPost-Pre = 0 versus the alternative H1: ΔPost-Pre ≠ 0. Results will be used as preliminary estimates to inform a subsequent larger trial.
Measured: From treatment initiation through 3 months
Secondary outcomes (4)
Participant change in the following T-cell subsets: T-regulatory; T-Effector Memory (T-EM); T-Effector Memory expressing RA (T-EMRA)
The within participant change in the following T-cell subsets will be estimated: T-regulatory, T-EM, T-EMRA. Mixed effects regression models will be utilized to estimate changes. Random effects will be included to account for the longitudinally correlated nature of repeated measurements. Graphical plots of the estimated mean and associated 95% confidence intervals by time point in the study will be produced.
Measured: From treatment initiation through 3 months
The proportion of participants with grade 3 or higher CRS
The rate of grade ≥3 CRS will be defined as the proportion of participants who develop grade 3 or higher CRS. The rate of grade ≥3 CRS will be reported as a binomial proportion along with a two-sided 95% confidence interval.
Measured: From treatment initiation through 3 months
The proportion of participants with grade 3 or highter ICANS
The rate of grade ≥3 ICAN will be defined as the proportion of participants who develop grade 3 or higher ICAN. The rate of grade ≥3 ICAN will be reported as a binomial proportion along with a two-sided 95% confidence interval.
Measured: From treatment initiation through 3 months
The proportion of participants with a very good partial response (VGPR) or better at 3 months
The 3-month response rate will be defined as the proportion of participants with a very good partial response (VGPR) or better at 3 months. The 3-month response rate will be reported as a binomial proportion along with a two-sided 95% confidence interval.
Measured: Three months after the initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christopher Strouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christopher Strouse, University of Iowa
- Investigators
- Christopher Strouse, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581704
- Sponsor's protocol ID
- 202601163
- Status last verified
- Jun 2026
- First submitted
- 5 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07581704
- Acronym / sponsor ID
- 202601163
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Christopher StrouseUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase Ib trial with expansion cohort to assess the safety and estimate the preliminary efficacy of sirolimus pre-conditioning prior to treatment with a T-cell engaging bispecific antibody in patients with relapsed / refractory multiple myeloma previously exposed to T-cell engager therapy. Following Phase Ib, the study will enroll an expansion cohort to test the hypothesis that sirolimus pre-conditioning will result in an increase in the Teffector: Texhausted -cell ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sirolimus in combination with teclistamab or talquetamab | Experimental | Drug: Sirolimus, Biological: Teclistamab, Biological: TalquetambThis study is designed to test changes in immune cell populations of patients with multiple myeloma exposed to short pre-conditioning with sirolimus prior to teclistamab or talquetamab. Safety of the combination will also be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (22 listed)
- 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:
- History of allogeneic hematopoietic cell transplantation.
- Excluded concurrent medical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SirolimusAlso: RapamycinSirolimus is an immunosuppressant drug. Sirolimus binds to FK binding protein 12 and inhibits mTOR. This then suppresses T-cell proliferation and inhibits progression from G1 to S phase of the cell cycle. | Drug | Sirolimus in combination with teclistamab or talquetamab |
| TeclistamabAlso: TecvayliTeclistamab is a bispecific antibody that binds the CD3 receptor on T-cells and the B-cell maturation antigen on multiple myeloma cells and healthy B-lineage cells. | Biological | Sirolimus in combination with teclistamab or talquetamab |
| TalquetambAlso: TalveyTalquetamab is a bispecific antibody that binds the CD3 receptor on T-cells and the GPRC5d receptor on multiple myeloma cells. | Biological | Sirolimus in combination with teclistamab or talquetamab |
Primary outcome
Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: From treatment initiation through 30 days post last dose of study treatment
The incidence of treatment-emergent adverse events will be summarized by system organ class and/or preferred term, type of adverse event, severity (based on NCI CTCAE v5.0) grades), and relation to study treatment. The most severe grade per participant will be reported. Adverse events leading to premature discontinuation from the study intervention and serious treatment-emergent adverse events will be presented in tabular form.
Expansion Cohort: Participants change in the Teffector: Texhausted cell ratio
Time frame: From treatment initiation through 3 months
Testing the null hypothesis H0: ΔPost-Pre = 0 versus the alternative H1: ΔPost-Pre ≠ 0. Results will be used as preliminary estimates to inform a subsequent larger trial.
4 secondary outcomes
Participant change in the following T-cell subsets: T-regulatory; T-Effector Memory (T-EM); T-Effector Memory expressing RA (T-EMRA)
Time frame: From treatment initiation through 3 months
The proportion of participants with grade 3 or higher CRS
Time frame: From treatment initiation through 3 months
The proportion of participants with grade 3 or highter ICANS
Time frame: From treatment initiation through 3 months
The proportion of participants with a very good partial response (VGPR) or better at 3 months
Time frame: Three months after the initiation of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christopher Strouse, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sirolimus, Teclistamab and Talquetamb in people with Multiple Myeloma, run by Christopher Strouse at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Strouse, MD ((319) 356-0489, christopher-strouse@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (time frame: From treatment initiation through 30 days post last dose of study treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.