ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- University of Washington
- Study ID
- NCT06588660
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Recurrent Multiple Myeloma
- Refractory Multiple Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vevoctadekin — BIOLOGICALGiven SC
- Bone Marrow Aspiration — PROCEDUREUndergo bone marrow aspiration and biopsy
- Bone Marrow Biopsy — PROCEDUREUndergo bone marrow aspiration and biopsy
- Medical Chart Review — OTHERAncillary studies
- Teclistamab — DRUGGiven SC
- Biospecimen Collection — PROCEDUREUndergo blood sample collection
Study Details
This phase Ib trial tests the safety, side effects and best dose of ST-067 in combination with teclistamab and how well it works in treating patients with multiple myeloma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen (BCMA), a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving ST-067 in combination with teclistamab may be safe, tolerable and/or effective in treating patients with relapsed or refractory multiple myeloma.
Key Dates
- Start date
- Dec 18, 2024
- Status verified
- Jul 2025
- Primary completion
- Feb 14, 2025
- Completion
- Feb 14, 2025
Study Design
- Enrollment
- 1 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (ST-067, teclistamab)Patients receive ST-067 SC on days 1, 8, 15 and 22 of cycle 1, on days 8, 15 and 22 of cycle 2, then on days 1 and 15 of subsequent cycles. Patients also receive teclistamab SC on days 1, 3, 5, 15 and 22 of cycle 2 then on days 1, 8, 15, and 22 or days 1 and 15 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the trial and bone marrow aspiration and biopsy during screening and on study.
Primary Outcome Measure
Monotherapy dose-limiting toxicities (DLT) rates [ Time Frame: Up to 28 days (cycle 1) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | - |
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