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WithdrawnNCT04217720Updated Aug 12, 2021

SNS-301 Monotherapy in High Risk MDS and CMML

A Phase 2 interventional study of SNS-301 in Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia (CMML), sponsored by Sensei Biotherapeutics, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Sensei Biotherapeutics, Inc. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Sponsor decision
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Myelodysplastic Syndromes
  • Chronic Myelomonocytic Leukemia (CMML)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

Browse Leukemia studies →

Lead sponsor

Sensei Biotherapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    SNS-301

    SNS-301

    Drug: SNS-301

Interventions

  • DrugSNS-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.

06

What researchers measure

Primary outcomes

  1. Adverse events of SNS-301

    Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0

    Time frame: 12 weeks

  2. Objective response rate by International Working Group (IWG) 2006 criteria

    Best objective response during the study

    Time frame: 12 weeks

  3. Minimal residual disease by IWG 2006 criteria

    Minimal residual disease by peripheral and bone marrow blast count during the study

    Time frame: 12 weeks

  4. Duration of Response by IWG 2006 criteria

    Duration of response calculated from date of first response to date of progression

    Time frame: 12 weeks

  5. Disease control rate (DCR) by IWG 2006 criteria

    Disease control rate calculated as the proportion of patients with stable disease or better

    Time frame: 12 weeks

  6. 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

    Time frame: 12 weeks

  7. Overall Survival

    Overall survival calculated from date of treatment to date of death

    Time frame: 36 months

Secondary outcomes

  1. 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

    Time frame: up to 12 weeks

  2. 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

    Time frame: up 12 weeks

  3. 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

    Time frame: up to 12 weeks

  4. 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

    Time frame: up to12 weeks

  5. 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

    Time frame: up to 12 weeks

  6. 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

    Time frame: up to 12 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04217720
Lead sponsor
Sensei Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
Jan 3, 2020
Start date
Apr 1, 2020 (estimated)
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Aug 12, 2021

Study contacts

Ildiko Csiki, MD, PhD
study director · Sensei Biotherapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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