Trial · NCT07581704
Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
NCT07581704, Phase 1, Recruiting, Christopher Strouse
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma. Trials, record NCT07581704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07581704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
- NCT number
- NCT07581704
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 10 participants, estimated
- Lead sponsor
- Christopher Strouse
- Conditions
- Multiple Myeloma
- Interventions
- Sirolimus, Teclistamab, Talquetamb
- First posted
- 2026-05-12
- Last updated
- 2026-06-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib: Dose limiting toxicities (DLTs) as measured by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | 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. |
| Primary | Expansion Cohort: Participants change in the Teffector: Texhausted cell ratio | 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. |
| Secondary | Participant change in the following T-cell subsets: T-regulatory; T-Effector Memory (T-EM); T-Effector Memory expressing RA (T-EMRA) | From treatment initiation through 3 months | 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. |
| Secondary | The proportion of participants with grade 3 or higher CRS | From treatment initiation through 3 months | 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. |
| Secondary | The proportion of participants with grade 3 or highter ICANS | From treatment initiation through 3 months | 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. |
| Secondary | The proportion of participants with a very good partial response (VGPR) or better at 3 months | Three months after the initiation of treatment | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07581704
GET https://conductscience.org/api/trials/v1/NCT07581704/registered