Recurrent Multiple MyelomaPhase 1NCT06588660
ST-067 and Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
A Phase 1 study testing Vevoctadekin, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by University of Washington at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- Vevoctadekin, Bone Marrow Aspiration and Bone Marrow Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2024to 14 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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 or therapies, including investigational drugs, within 7 days of Cycle 1 Day 1
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- Corticosteroids for other purposes, including for pain control, are allowed during the screening period but must also be stopped ≥ 7 days prior to Cycle 1 Day 1
- Similarly, focal radiation therapy for palliative purposes is permitted during the screening period but must also be completed ≥ 7 days prior to Cycle 1 Day 1
- Known central nervous system (CNS) involvement of MM at time of study screening
- Known 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Phase 1b Study of ST-067 (Decoy-Resistant IL-18) With Teclistamab in Multiple Myeloma
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.
Read the 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, 8, 15, and 22 or 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 during screening and on study.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
- Being tested
- Vevoctadekin, Bone Marrow Aspiration, Bone Marrow Biopsy, Medical Chart Review, Teclistamab
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VevoctadekinBiological
Also called Engineered IL-18 Variant ST-067, Engineered Interleukin-18 Variant ST-067, ST 067, ST-067
Given SC
Bone Marrow AspirationProcedure or surgery
Undergo bone marrow aspiration and biopsy
Bone Marrow BiopsyProcedure or surgery
Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow
Undergo bone marrow aspiration and biopsy
Medical Chart ReviewOther
Also called Chart Review
Ancillary studies
TeclistamabDrug
Also called JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyv
Given SC
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Treatment (ST-067, teclistamab) | Experimental | 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. Receives: Biological: Vevoctadekin; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Other: Medical Chart Review; Drug: Teclistamab; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monotherapy dose-limiting toxicities (DLT) rates
Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria, while other toxicities will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.
Measured: Up to 28 days (cycle 1)
Combination therapy DLT rates
CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.
Measured: Up to 28 days (cycle 2)
Optimal biological dose (OBD)
OBD will be determined based on a composite of clinical information, including safety, tolerability, optimal biological effects without undesirable clinical effects, and biological response data.
Measured: Up to 28 days
Incidence of adverse events (AEs)
The types, frequencies and severity of AEs will be analyzed. CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0.
Measured: Up to 30 days after last dose of ST-067
Secondary outcomes (5)
Overall response rate (ORR)
Responses will be assessed per International Myeloma Working Group criteria. ORR will be summarized along with the 2-sided 95% exact Clopper-Pearson confidence interval.
Measured: At months 1 and 3
Minimal residual disease (MRD) negativity
Bone marrow will be assessed using next generation sequencing for achievement of MRD negativity (threshold 10^-5) and will be compared across all enrolled participants and within each individual.
Measured: At 1 month after initiation of teclistamab
Duration of response (DOR)
Kaplan-Meier method will be used to analyze DOR.
Measured: Up to 5 years
Progression-free survival (PFS)
PFS will be calculated using assessments by investigators. Kaplan-Meier methodology will be used to estimate event-free curves and corresponding quartiles (including the median).
Measured: From first dose of teclistamab to disease progression or death up to 5 years
Overall survival (OS)
Kaplan-Meier methodology will be used to estimate OS curves.
Measured: From first dose of teclistamab to death up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start18 Dec 2024
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Why it stopped: Study terminated due to end of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Simcha Therapeutics
- Responsible party
- Sponsor
- Investigators
- Rahul Banerjee, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06588660
- Sponsor's protocol ID
- RG1123948
- Other IDs
- NCI-2024-07236, 20589
- Status last verified
- Jul 2025
- First submitted
- 6 Sep 2024
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Study of ST-067 (Decoy-Resistant IL-18) With Teclistamab in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT06588660
- Acronym / sponsor ID
- RG1123948
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to end of funding.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Simcha Therapeutics
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 8, 15, and 22 or 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 during screening and on study.
After completion of study treatment, patients are followed every 3 months for up to 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (ST-067, teclistamab) | Experimental | Biological: Vevoctadekin, Procedure: Bone Marrow Aspiration, Procedure: Bone Marrow Biopsy, Other: Medical Chart Review, Drug: Teclistamab, Procedure: Biospecimen CollectionPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
- 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
- Age ≥ 18 at study screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
Key exclusion criteria (13 listed)
- 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
- 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
- Concurrent use of other anti-MM agents or therapies, including investigational drugs, within 7 days of Cycle 1 Day 1
- Known central nervous system (CNS) involvement of MM at time of study screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VevoctadekinAlso: Engineered IL-18 Variant ST-067, Engineered Interleukin-18 Variant ST-067, ST 067, ST-067Given SC | Biological | Treatment (ST-067, teclistamab) |
| Bone Marrow AspirationUndergo bone marrow aspiration and biopsy | Procedure or surgery | Treatment (ST-067, teclistamab) |
| Bone Marrow BiopsyAlso: Biopsy of Bone Marrow, Biopsy, Bone MarrowUndergo bone marrow aspiration and biopsy | Procedure or surgery | Treatment (ST-067, teclistamab) |
| Medical Chart ReviewAlso: Chart ReviewAncillary studies | Other | Treatment (ST-067, teclistamab) |
| TeclistamabAlso: JNJ 64007957, JNJ-64007957, JNJ64007957, Teclistamab-cqyvGiven SC | Drug | Treatment (ST-067, teclistamab) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo blood sample collection | Procedure or surgery | Treatment (ST-067, teclistamab) |
Primary outcome
Monotherapy dose-limiting toxicities (DLT) rates
Time frame: Up to 28 days (cycle 1)
Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be graded using American Society for Transplantation and Cellular Therapy (ASTCT) criteria, while other toxicities will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.
Combination therapy DLT rates
Time frame: Up to 28 days (cycle 2)
CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0. DLT rates at each dose level will be estimated by isotonic regression by applying the pooled adjacent violators algorithm.
Optimal biological dose (OBD)
Time frame: Up to 28 days
OBD will be determined based on a composite of clinical information, including safety, tolerability, optimal biological effects without undesirable clinical effects, and biological response data.
Incidence of adverse events (AEs)
Time frame: Up to 30 days after last dose of ST-067
The types, frequencies and severity of AEs will be analyzed. CRS and ICANS will be graded using ASTCT criteria, while other toxicities will be graded using CTCAE v 5.0.
5 secondary outcomes
Overall response rate (ORR)
Time frame: At months 1 and 3
Minimal residual disease (MRD) negativity
Time frame: At 1 month after initiation of teclistamab
Duration of response (DOR)
Time frame: Up to 5 years
Progression-free survival (PFS)
Time frame: From first dose of teclistamab to disease progression or death up to 5 years
Overall survival (OS)
Time frame: From first dose of teclistamab to death up to 5 years
Results and safety
The study was stopped early (reason given: Study terminated due to end of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahul Banerjee, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vevoctadekin, Bone Marrow Aspiration and Bone Marrow Biopsy in people with Recurrent Multiple Myeloma and Refractory Multiple Myeloma, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to end of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monotherapy dose-limiting toxicities (DLT) rates (time frame: Up to 28 days (cycle 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.