Myelodysplastic SyndromesPhase 2NCT04217720
SNS-301 Monotherapy in High Risk MDS and CMML
A Phase 2 study testing SNS-301 in people with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia (CMML), run by Sensei Biotherapeutics, Inc..
Trial summary
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia (CMML)
- What is being tested?
- SNS-301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Jan 2023
- Phase
- Phase 2
- 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
- Signed informed consent.
- Be 18 years of age or older.
- Confirmed diagnosis of MDS or CMML.
- Assessment of high-risk-MDS/CMML status defined as follows:
- MDS: IPSS-R criteria for categorization ≥ Intermediate Risk-3
- CMML: WHO criteria for CMML-2 (peripheral blasts of 5% to 19%, and 10% to 19% bone marrow blasts and/or presence of Auer rods).
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- Be willing to provide a fresh bone marrow aspirate sample at pre-treatment and demonstrate ASPH expression by flow cytometry.
- Patient who has relapsed or is refractory / intolerant of hypomethylating agents (HMAs) or not responding to 4 treatment cycles of decitabine or 6 treatment cycles of azacytidine or progressing at any point after initiation of an HMA.
- Patient refuses or is not considered a candidate for intensive induction chemotherapy using consensus criteria for defining such patients.
- Patients with CMML must have been treated with at least 1 prior therapy (hydroxyurea or an HMA).
- Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
- Demonstrate adequate organ function: renal, hepatic, coagulation parameters.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two highly effective contraceptive methods during the treatment period and for at least 180 days after the last dose of study treatment. For male patients: Agree that during the period specified above, men will not father a child. Male patients must remain abstinent, must be surgically sterile during the treatment period and for at least 180 days after the last dose of study treatment.
Who cannot join
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
- Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
- Malignancies other than indications open for enrollment within 3 years prior to Day 0.
- Diagnosis of a core binding factor leukemia (t(8;21), t(16;16); or inv(16)) or diagnosis of acute promyelocytic leukemia (t(15;17)).
- Active or history of autoimmune disease or immune deficiency.
- History of HIV. HIV antibody testing recommended per investigator's clinical suspicion.
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- Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigator's clinical suspicion.
- Severe infections within 4 weeks prior to enrollment.
- Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.
- History or current evidence of any condition, therapy or laboratory abnormality that in the opinion of the treating investigator might confound the results of the trial.
- Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
- Treatment with systemic immunomodulating agents (including but not limited to IFNs, IL-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to first dose.
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study.
About this study
Official title: An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.
Read the detailed description
This phase 2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of intradermally-delivered SNS-301 delivered using the 3M® hollow microstructured transdermal system (hMTS) device in patients with ASPH+ high risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial population consists of high risk ≥ Intermediate Risk-3 (IR-3) MDS and CMML-2.
- Being tested
- SNS-301
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNS-301Drug
SNS-301 (1x 1011 dose/1ml) ID injection every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, and thereafter every 12 weeks up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| SNS-301 | Experimental | SNS-301 Receives: Drug: SNS-301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events of SNS-301
Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Measured: 12 weeks
Objective response rate by International Working Group (IWG) 2006 criteria
Best objective response during the study
Measured: 12 weeks
Minimal residual disease by IWG 2006 criteria
Minimal residual disease by peripheral and bone marrow blast count during the study
Measured: 12 weeks
Duration of Response by IWG 2006 criteria
Duration of response calculated from date of first response to date of progression
Measured: 12 weeks
Disease control rate (DCR) by IWG 2006 criteria
Disease control rate calculated as the proportion of patients with stable disease or better
Measured: 12 weeks
Progression Free Survival (PFS) as assessed by IWG 2006 criteria
Progression free survival calculated from the date of start of treatment to date of progression
Measured: 12 weeks
Overall Survival
Overall survival calculated from date of treatment to date of death
Measured: 36 months
Secondary outcomes (6)
Measurement of ASPH specific responses
Evaluate blood and tissue ASPH-specific responses at pretreatment, changes during treatment and at progression or end of study in all study participants where sample is available for analysis
Measured: up to 12 weeks
Measurement of T cell immune response
Characterize blood and bone marrow T cell types and numbers at pretreatment, changes during treatment and at progression or end of study in all study participants where sample is available for analysis
Measured: up 12 weeks
Measurement B cell immune responses
Characterize blood and bone marrow B cell numbers at pretreatment, changes during treatment and at progression or end of study in all study participants where sample is available for analyses
Measured: up to 12 weeks
Evaluation of immune gene transcript profiles
Determine changes in commercially available gene signature panels in blood and bone marrow pretreatment, during treatment and at progression in all study participants where sample is available for analysis
Measured: up to12 weeks
Measurement of pro-inflammatory and/or immunosuppressive molecules
The immunological response of pro-inflammatory/immunosuppressive molecules will be observed before, during and after treatment using commercially available assays. Analyses will be performed both on blood and bone marrow samples in all study participants where sample is available for analysis
Measured: up to 12 weeks
Measurement of oncoprotein expression
Changes in oncoprotein levels will be evaluated before, during and after treatment using methods such as flow cytometry. Analyses will be performed both on blood and bone marrow samples in all study participants where sample is available for analysis
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensei Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ildiko Csiki, MD, PhD, Study director, Sensei Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217720
- Sponsor's protocol ID
- SNS-301-2-1
- Status last verified
- Aug 2021
- First submitted
- 31 Oct 2019
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
- ClinicalTrials.gov ID
- NCT04217720
- Acronym / sponsor ID
- SNS-301-2-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sensei Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 3 Jan 2020 (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.
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.
Detailed description
This phase 2, open-label, multi-center trial to evaluate the safety, immunogenicity and preliminary clinical efficacy of intradermally-delivered SNS-301 delivered using the 3M® hollow microstructured transdermal system (hMTS) device in patients with ASPH+ high risk myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML). The trial population consists of high risk ≥ Intermediate Risk-3 (IR-3) MDS and CMML-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SNS-301 | Experimental | Drug: SNS-301SNS-301 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed informed consent.
- Be 18 years of age or older.
- Confirmed diagnosis of MDS or CMML.
- Assessment of high-risk-MDS/CMML status defined as follows:
- Be willing to provide a fresh bone marrow aspirate sample at pre-treatment and demonstrate ASPH expression by flow cytometry.
Key exclusion criteria (13 listed)
- Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
- Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
- Malignancies other than indications open for enrollment within 3 years prior to Day 0.
- Diagnosis of a core binding factor leukemia (t(8;21), t(16;16); or inv(16)) or diagnosis of acute promyelocytic leukemia (t(15;17)).
- Active or history of autoimmune disease or immune deficiency.
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 |
|---|---|---|
| SNS-301SNS-301 (1x 1011 dose/1ml) ID injection every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, and thereafter every 12 weeks up to 24 months. | Drug | SNS-301 |
Primary outcome
Adverse events of SNS-301
Time frame: 12 weeks
Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Objective response rate by International Working Group (IWG) 2006 criteria
Time frame: 12 weeks
Best objective response during the study
Minimal residual disease by IWG 2006 criteria
Time frame: 12 weeks
Minimal residual disease by peripheral and bone marrow blast count during the study
Duration of Response by IWG 2006 criteria
Time frame: 12 weeks
Duration of response calculated from date of first response to date of progression
Disease control rate (DCR) by IWG 2006 criteria
Time frame: 12 weeks
Disease control rate calculated as the proportion of patients with stable disease or better
Progression Free Survival (PFS) as assessed by IWG 2006 criteria
Time frame: 12 weeks
Progression free survival calculated from the date of start of treatment to date of progression
Overall Survival
Time frame: 36 months
Overall survival calculated from date of treatment to date of death
6 secondary outcomes
Measurement of ASPH specific responses
Time frame: up to 12 weeks
Measurement of T cell immune response
Time frame: up 12 weeks
Measurement B cell immune responses
Time frame: up to 12 weeks
Evaluation of immune gene transcript profiles
Time frame: up to12 weeks
Measurement of pro-inflammatory and/or immunosuppressive molecules
Time frame: up to 12 weeks
Measurement of oncoprotein expression
Time frame: up to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underline the results reported in the article, after deidentification (text, tables, figures and appendices) will be shared to researchers who have provide a methodologically sound proposal and sign a data access agreement.
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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.
Ildiko Csiki, MD, PhD study director
Sensei Biotherapeutics
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNS-301 in people with Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia (CMML), run by Sensei Biotherapeutics, Inc..
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 13 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: withdrawn, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Adverse events of SNS-301 (time frame: 12 weeks). The study lists 7 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 12 Aug 2021.