20 Participants Needed

ST-067 + Teclistamab for Multiple Myeloma

RB
Overseen ByRahul Banerjee, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Washington
Must be taking: Teclistamab
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Teclistamab, a part of the treatment, has shown effectiveness in treating multiple myeloma, with a response rate of over 60% in patients who have tried several other treatments. It works by helping the immune system target and destroy cancer cells.12345

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?

ST-067 + Teclistamab is unique because it combines a novel decoy-resistant IL-18 with a bispecific antibody that targets both multiple myeloma cells and activates T cells, potentially overcoming drug resistance and enhancing anti-myeloma immunity.7891011

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

RB

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

Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min
My multiple myeloma meets specific medical criteria.
I am able to get out of my bed or chair and move around.
See 10 more

Exclusion Criteria

My multiple myeloma has spread to my brain or spinal cord.
I have been in remission from any other cancer for at least 1 year.
Current or planned pregnancy or breastfeeding within the next 12 months
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

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.

Up to 5 years
Multiple visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-ups every 3 months.

Up to 5 years
Every 3 months (in-person)

Treatment Details

Interventions

  • ST-067
  • Teclistamab
Trial Overview The trial is testing the safety and optimal dosage of ST-067 combined with teclistamab in treating relapsed or refractory multiple myeloma. ST-067 enhances immune response against cancer cells, while teclistamab targets proteins on B-cells and T-cells potentially inhibiting cancer growth.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (ST-067, teclistamab)Experimental Treatment6 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Simcha Therapeutics

Collaborator

Trials
2
Recruited
40+

Findings from Research

Teclistamab, a bispecific antibody targeting CD3 and BCMA, has received conditional approval in the EU and full approval in the US for treating adult patients with relapsed or refractory multiple myeloma after multiple prior therapies.
The approvals are based on its efficacy in patients who have undergone at least three to four previous treatments, including specific types of therapies, highlighting its role as a treatment option for difficult-to-treat cases of multiple myeloma.
Teclistamab: First Approval.Kang, C.[2022]
Teclistamab-cqyv is a bispecific T-cell engager antibody that effectively activates the immune system to target multiple myeloma cells, showing an overall response rate of over 60% in heavily pretreated patients.
The side effect profile of teclistamab-cqyv is more tolerable compared to other BCMA-targeted therapies, making it a suitable treatment option for elderly patients with relapsed or refractory multiple myeloma, and it has received FDA approval for use as monotherapy.
Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma.Hua, G., Scanlan, R., Straining, R., et al.[2023]
Teclistamab, a bispecific antibody targeting B-cell maturation antigen and CD3, has shown promising efficacy in treating relapsed/refractory multiple myeloma, with the recommended Phase II dose established at 1.5 mg/kg subcutaneously, which maintains drug levels above the effective concentration needed for maximum cytotoxicity.
The study utilized pharmacokinetic modeling to predict effective dosing ranges, confirming that doses of 0.27 mg/kg and 0.72 mg/kg intravenously, as well as 0.72 mg/kg subcutaneously, achieved serum concentrations that correlate with effective treatment outcomes.
Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma.Girgis, S., Lin, SXW., Pillarisetti, K., et al.[2022]

References

Teclistamab: First Approval. [2022]
Teclistamab-cqyv: The First Bispecific T-Cell Engager Antibody for the Treatment of Patients With Relapsed or Refractory Multiple Myeloma. [2023]
Translational Modeling Predicts Efficacious Therapeutic Dosing Range of Teclistamab for Multiple Myeloma. [2022]
Teclistamab-cqyv in multiple myeloma. [2023]
Teclistamab in Relapsed or Refractory Multiple Myeloma. [2023]
Teclistamab for Multiple Myeloma: Clinical Insights and Practical Considerations for a First-in-Class Bispecific Antibody. [2023]
Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. [2021]
Hematologic Malignancies: Plasma Cell Disorders. [2019]
Novel therapeutic approaches for multiple myeloma. [2019]
Targeting TGF-β signaling in the multiple myeloma microenvironment: Steering CARs and T cells in the right direction. [2023]
Mechanism of immunomodulatory drug resistance and novel therapeutic strategies in multiple myeloma. [2022]
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