Impact of Sirolimus Pre-conditioning on T Cell Activity and T-cell Engaging Bispecific Antibody Efficacy in Multiple Myeloma
Christopher Strouse
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 bispe…
Interventions
- DrugSirolimus
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.
- BiologicalTeclistamab
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.
- BiologicalTalquetamb
Talquetamab is a bispecific antibody that binds the CD3 receptor on T-cells and the GPRC5d receptor on multiple myeloma cells.
Location
- University of Iowa Health CareIowa City, Iowa