ST-067 + Teclistamab for Multiple Myeloma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot use other anti-multiple myeloma drugs within 7 days of screening. Also, you cannot take certain steroids or immunosuppressive medications within 14 days of starting the study drugs.
What data supports the effectiveness of the drug ST-067 + Teclistamab for Multiple Myeloma?
Is the combination of ST-067 and Teclistamab safe for humans?
Teclistamab, also known as teclistamab-cqyv or Tecvayli, has been approved for treating multiple myeloma and has shown a more tolerable side effect profile compared to similar treatments, especially for elderly patients. However, it can cause side effects like cytokine release syndrome (a severe immune reaction), infections, and neurotoxicity (nerve damage), so doctors take special precautions to manage these risks.12346
How is the drug ST-067 + Teclistamab unique for treating multiple myeloma?
What is the purpose of this trial?
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.
Research Team
Rahul Banerjee, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Eligibility Criteria
This trial is for patients with multiple myeloma that has either returned after a period of remission or hasn't improved with previous treatments. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have specific characteristics related to their condition.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive ST-067 and teclistamab subcutaneously in a dose-escalation and dose-expansion study. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months.
Treatment Details
Interventions
- ST-067
- Teclistamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Simcha Therapeutics
Collaborator