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SNS-301 Monotherapy in High Risk MDS and CMML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217720
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Sensei Biotherapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 31, 2019
First Posted Date  ICMJE January 3, 2020
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2020)
  • Measurement of ASPH specific responses [ Time Frame: up to 12 weeks ]
    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
  • Measurement of T cell immune response [ Time Frame: up 12 weeks ]
    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
  • Measurement B cell immune responses [ Time Frame: up to 12 weeks ]
    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
  • Evaluation of immune gene transcript profiles [ Time Frame: up to12 weeks ]
    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
  • Measurement of pro-inflammatory and/or immunosuppressive molecules [ Time Frame: up to 12 weeks ]
    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
  • Measurement of oncoprotein expression [ Time Frame: up to 12 weeks ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SNS-301 Monotherapy in High Risk MDS and CMML
Official Title  ICMJE An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia (CMML)
Intervention  ICMJE Drug: SNS-301
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 Arms  ICMJE Experimental: SNS-301
SNS-301
Intervention: Drug: SNS-301
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 2, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2023
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Signed informed consent.
  2. Be 18 years of age or older.
  3. Confirmed diagnosis of MDS or CMML.
  4. Assessment of high-risk-MDS/CMML status defined as follows:

    1. MDS: IPSS-R criteria for categorization ≥ Intermediate Risk-3
    2. 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).
  5. Be willing to provide a fresh bone marrow aspirate sample at pre-treatment and demonstrate ASPH expression by flow cytometry.
  6. 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.
  7. Patient refuses or is not considered a candidate for intensive induction chemotherapy using consensus criteria for defining such patients.
  8. Patients with CMML must have been treated with at least 1 prior therapy (hydroxyurea or an HMA).
  9. Eastern Cooperative Oncology Group (ECOG) Performance Scale 0-1.
  10. Demonstrate adequate organ function: renal, hepatic, coagulation parameters.
  11. 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.

Exclusion Criteria:

  1. Any approved anti-cancer therapy including chemotherapy, targeted small molecule therapy or radiation therapy within 2 weeks prior to trial Day 0.
  2. Participated on a clinical trial of an investigational agent and/or investigational device within 28 days prior to Day 0.
  3. Malignancies other than indications open for enrollment within 3 years prior to Day 0.
  4. 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)).
  5. Active or history of autoimmune disease or immune deficiency.
  6. History of HIV. HIV antibody testing recommended per investigator's clinical suspicion.
  7. Active hepatitis B (hepatitis B surface antigen reactive) or active hepatitis C (HCV qualitative RNA detected); testing recommended per investigator's clinical suspicion.
  8. Severe infections within 4 weeks prior to enrollment.
  9. Received therapeutic oral or IV antibiotics within 2 weeks prior to Day 0.
  10. 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.
  11. Known previous or ongoing, active psychiatric or substance abuse disorders that would interfere with the requirements of the trial.
  12. 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.
  13. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Alice Drumheller 2404548027 adrumheller@senseibio.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04217720
Other Study ID Numbers  ICMJE SNS-301-2-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: Beginning 9 months and ending 36 months following article publication.
Access Criteria: Access will be considered to researchers who provide a methodologically sound proposal. Analysis must achieve the aims outlined in the approved proposal Proposals should be directed to info@senseibio.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 36 months following article publication.
Responsible Party Sensei Biotherapeutics, Inc.
Study Sponsor  ICMJE Sensei Biotherapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ildiko Csiki, MD, PhD Sensei Biotherapeutics
PRS Account Sensei Biotherapeutics, Inc.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP