SNS-301 Monotherapy in High Risk MDS and CMML

NCT04217720 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: SNS-301-2-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia (CMML)

Outcome Measures

Primary Outcomes (7)

• Adverse events of SNS-301

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

  12 weeks

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

  Best objective response during the study

  12 weeks

• Minimal residual disease by IWG 2006 criteria

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

  12 weeks

• Duration of Response by IWG 2006 criteria

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

  12 weeks

• Disease control rate (DCR) by IWG 2006 criteria

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

  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

  12 weeks

• Overall Survival

  Overall survival calculated from date of treatment to date of death

  36 months

Secondary Outcomes (6)

• Measurement of ASPH specific responses

  up to 12 weeks

• Measurement of T cell immune response

  up 12 weeks

• Measurement B cell immune responses

  up to 12 weeks

• Evaluation of immune gene transcript profiles

  up to12 weeks

• Measurement of pro-inflammatory and/or immunosuppressive molecules

  up to 12 weeks

Study Arms (1)

SNS-301

EXPERIMENTAL

SNS-301

Drug: SNS-301

Interventions

SNS-301 DRUG

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.

SNS-301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sensei Biotherapeutics, Inc.: lead

MeSH Terms

Conditions

Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myelodysplastic-Myeloproliferative Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ildiko Csiki, MD, PhD

  Sensei Biotherapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: January 3, 2020
• Study Start: April 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2023
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.