Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07200102
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Selinexor — DRUG
    Selinexor will be provided by Karyopharm Therapeutics, Inc.

Study Details

The outcomes in patients with relapsed multiple myeloma refractory to triple-therapy (anti-CD38, immunomodulatory drugs (IMiD) and proteasome inhibitors (PI)) remain poor. These patients are eligible for chimeric antigen receptor T-cells (CAR-T), which rely on redirecting autologous T-cells to clear myeloma cells by targeting B-cell maturation antigen (BCMA). BCMA CAR-T therapy is not curative, and unlike autologous stem cell transplant, there is currently no standard for maintenance therapy post CAR-T which could potentially increase MRD rates and extend progression-free survival. Selinexor is an exportin (XPO1) inhibitor with direct anti-tumor effect used often as an adjunct with other agents as bridging therapy prior to CAR-T. As selinexor does not affect T-cell yields or fitness, T-cell collection on selinexor for CAR-T manufacturing is safe. The aim of this study is to evaluate the safety and toxicity of selinexor in triple-exposed or refractory multiple myeloma patients with high-risk features (adverse risk cytogenetics, less than complete response (CR) post CAR-T, or extramedullary disease) following BCMA CAR-T therapy. The investigators hypothesize that selinexor as maintenance therapy following CAR-T has the potential to act synergistically with CAR-T cells leading to more durable responses.

Key Dates

Start date
Mar 17, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2029
Completion
Mar 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Selinexor
    Patients with high risk of relapse will receive maintenance selinexor starting at Day 30 (high risk MM patients) or after Day 58 (for MRD+ patients) post-cilta-cel infusion and will continue selinexor for up to 12 cycles. Selinexor will be given weekly on Days 1, 8, 15, and 22 of each 28-day cycle. The first 3 to 6 patients enrolled will be part of the safety run-in cohort; these patients will be monitored for dose-limiting toxicities during Cycle 1.

Primary Outcome Measure

Rate of non-hematologic grade ≥ 3 treatment-related adverse events (excluding conditioning and CAR-T related adverse events) according to CTCAE v 6.0 [ Time Frame: From start of selinexor through 30 days after the last dose of selinexor (estimated to be 13 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Mark A Schroeder, M.D.
[email protected]
314-454-8306
Mark A Schroeder, M.D. (PRINCIPAL_INVESTIGATOR)
Arun Cumpelik, M.D., Ph.D. (SUB_INVESTIGATOR)
Feng Gao, Ph.D. (SUB_INVESTIGATOR)
Ravi Vij, M.D. (SUB_INVESTIGATOR)
Michael Slade, M.D. (SUB_INVESTIGATOR)
Keith Stockerl-Goldstein, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Washington University School of Medicine· St Louis, MO

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