Trial Title:
ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
NCT ID:
NCT06588660
Condition:
Recurrent Multiple Myeloma
Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Vevoctadekin
Description:
Given SC
Arm group label:
Treatment (ST-067, teclistamab)
Other name:
Engineered IL-18 Variant ST-067
Other name:
Engineered Interleukin-18 Variant ST-067
Other name:
ST 067
Other name:
ST-067
Other name:
ST067
Intervention type:
Procedure
Intervention name:
Bone Marrow Aspiration
Description:
Undergo bone marrow aspiration and biopsy
Arm group label:
Treatment (ST-067, teclistamab)
Intervention type:
Procedure
Intervention name:
Bone Marrow Biopsy
Description:
Undergo bone marrow aspiration and biopsy
Arm group label:
Treatment (ST-067, teclistamab)
Other name:
Biopsy of Bone Marrow
Other name:
Biopsy, Bone Marrow
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Ancillary studies
Arm group label:
Treatment (ST-067, teclistamab)
Other name:
Chart Review
Intervention type:
Drug
Intervention name:
Teclistamab
Description:
Given SC
Arm group label:
Treatment (ST-067, teclistamab)
Other name:
JNJ 64007957
Other name:
JNJ-64007957
Other name:
JNJ64007957
Other name:
Teclistamab-cqyv
Other name:
Tecvayli
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (ST-067, teclistamab)
Other name:
Biological Sample Collection
Summary:
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.
Detailed description:
OUTLINE: This is a dose-escalation study of ST-067 in combination with teclistamab
followed by a dose-expansion study.
Patients receive ST-067 subcutaneously (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 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 on study.
After completion of study treatment, patients are followed every 3 months for up to 5
years.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Multiple myeloma, as defined by the presence of at least one International Myeloma
Working Group (IMWG) MM-defining event
- Measurable disease as defined by IMWG criteria, requiring one or more of the
following:
- Serum M-protein ≥ 0.5 g/dL
- Urine M-protein ≥ 200 mg/24h
- Involved serum free light chain ratio ≥ 10 mg/dL with abnormal kappa/lambda
ratio
- Measurable plasmacytoma, defined as ≥ 1 lesion with cross-sectional diameter ≥
2 centimeters)
- Bone marrow plasma cell percentage ≥ 30%
- Eligibility to receive commercial tec per the Food and Drug Administration (FDA)
package insert. This requires (1) at least 4 prior lines of therapy including a
proteasome inhibitor (PI), immune modulatory imide drug (IMID), and CD38 monoclonal
antibody (mAb); and (2) refractoriness, intolerance, or ineligibility (as deemed by
the patient's treating physician) to other established therapies known to provide
clinical benefit in MM
- If the FDA package insert for tec is changed to allow for its use in earlier
lines of therapy, the above-mentioned stipulations still apply until a protocol
modification is approved
- Age ≥ 18 at study screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Anticipated survival of > 3 months
- Estimated glomerular filtration rate (eGFR) ≥ 40 mL/min using the Modification of
Diet in Renal Disease equation
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both ≤ 3 x the
lab's upper limit of normal (ULN)
- Total bilirubin ≤ 2 x ULN
- Platelets ≥ 25,000/μL at screening (no more than 1 transfusion in the 7-day period
leading up to screening labs)
- Hemoglobin ≥ 7 g/dL at screening (no more than 1 transfusion in the 7-day period
leading up to screening labs)
- Absolute neutrophil count (ANC) ≥ 1000 cells/mm^3 at screening (no more than one
administration of growth factor in the 7-day period leading up to screening labs)
- For patients of reproductive potential only: Willingness to use an effective
contraceptive method before, during, and for at least 5 months after the last dose
of study therapy
- Ability to understand and provide informed consent as well as willingness to comply
with study requirements including visits and biopsies
Exclusion Criteria:
- History of prior BCMA-directed therapy in the past 12 months
- History of another primary malignancy that has not been in remission for at least 1
year
- However, the following diagnoses are eligible for inclusion: non-melanoma skin
cancer, localized prostate cancer, superficial bladder cancer, cervical
carcinoma in situ, or any prior malignancy with an estimated > 90% 1-year cure
rate per sponsor-investigator
- Any condition requiring systemic treatment with corticosteroids (> 10mg daily
prednisone equivalent) or other immunosuppressive medications within 14 days of
study drug administration. This includes active cytokine release syndrome (CRS),
active graft-versus-host disease, or autoimmune conditions
- Inhaled or topical steroids are allowed, as are replacement corticosteroids for
adrenal insufficiency
- Concurrent use of other anti-MM agents, including investigational drugs, within 7
days of study screening
- Known central nervous system (CNS) involvement of MM at time of study screening
- Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) at time of
study screening
- Current pregnancy or breastfeeding, or planned pregnancy or breastfeeding within the
next 12 months
- Corrected QT (QTc) interval (Bazett formula) ≥ 500 milliseconds on screening
electrocardiogram (ECG)
- Uncontrolled or concurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance
with study requirements
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Contact:
Last name:
Rahul Banerjee, MD
Phone:
206-606-1453
Email:
rahulbanerjee@fredhutch.org
Investigator:
Last name:
Rahul Banerjee, MD
Email:
Principal Investigator
Start date:
February 1, 2025
Completion date:
December 31, 2026
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Collaborator:
Agency:
Simcha Therapeutics
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06588660
