Feasibility Study of Iberdomide (CC-220) Priming to Improve T Cell Fitness Prior to Leukapheresis for Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Relapsed/Refractory Multiple Myeloma (RRMM)
Shambavi Richard
Summary
This feasibility trial studies the efficacy of administering iberdomide (CC-220) as a priming agent prior to leukapheresis in patients with relapsed/refractory multiple myeloma (RRMM) who are already planned for standard-of-care CAR-T therapy. Giving iberdomide before CAR-T may improve T cell fitness which may improve CAR-T expansion kinetics and response after infusion.
Description
In this feasibility study, patients with RRMM planned for standard of care CAR-T will be approached for consent for enrollment. Participating patients will receive one 28-day cycle of iberdomide at a dose of 1.0 mg daily, using a dosing schedule of 1.0 mg once daily for 21 days followed by 7 days off. After completion of the 28-day cycle, patients will proceed with leukapheresis on day 29 of therapy, with allowance for up to a 14-day delay in leukapheresis if needed. Blood samples will be collected on day 1 (prior to iberdomide exposure) and on the day of leukapheresis to compare T cell profil…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
INCLUSION CRITERIA * Subject is ≥18 years of age at the time of signing the informed consent form (ICF). * Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted. * Subject is willing and able to adhere to the study visit schedule and other protocol requirements. * All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with either cilta-cel or ide-cel. * All subjects must have ≥2 prior lines of multiple myeloma directed therapy, as determined by their treating clinician * All patients must h…
Interventions
- DrugIberdomide
1.0mg iberdomide capsules administered orally, daily on days 1-21 of a 28-day cycle
- ProcedureCAR-T Leukapheresis
A procedure in which blood is collected and white blood cells (including T cells) are separated and collected. The remaining blood components are returned to the participant. The collected T cells will be used to manufacture the CAR-T cell therapy.
- ProcedureCAR-T Infusion
Participants will receive an intravenous infusion of standard-of-care CAR-T therapy manufactured from the participant's previously collected cells
Location
- Icahn School of Medicine at Mount SinaiNew York, New York