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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.

Brief Summary:
To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia (CMML) Drug: SNS-301 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023


Arm Intervention/treatment
Experimental: SNS-301
SNS-301
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.




Primary Outcome Measures :
  1. 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

  2. Objective response rate by International Working Group (IWG) 2006 criteria [ Time Frame: 12 weeks ]
    Best objective response during the study

  3. Minimal residual disease by IWG 2006 criteria [ Time Frame: 12 weeks ]
    Minimal residual disease by peripheral and bone marrow blast count during the study

  4. Duration of Response by IWG 2006 criteria [ Time Frame: 12 weeks ]
    Duration of response calculated from date of first response to date of progression

  5. 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

  6. 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

  7. Overall Survival [ Time Frame: 36 months ]
    Overall survival calculated from date of treatment to date of death


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217720


Contacts
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Contact: Alice Drumheller 2404548027 adrumheller@senseibio.com

Sponsors and Collaborators
Sensei Biotherapeutics, Inc.
Investigators
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Study Director: Ildiko Csiki, MD, PhD Sensei Biotherapeutics
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Responsible Party: Sensei Biotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04217720    
Other Study ID Numbers: SNS-301-2-1
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Leukemia, Myeloid
Myelodysplastic-Myeloproliferative Diseases