NCT07573111

Brief Summary

Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
33mo left

Started Jun 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

May 1, 2026

Last Update Submit

May 1, 2026

Conditions

Acute LeukemiaMyelodysplastic Syndrome

Keywords

LeukemiaMyelodysplastic Syndrome (MDS)Acute Lymphocytic Leukemia (ALL)Acute Myeloid Leukemia (AML)trransplanthematopoietic stem cell transplant

Outcome Measures

Primary Outcomes (1)

  • Safety of QUAIL-100

    Incidence of treatment-emergent adverse events

    12 weeks after administration of QUAIL-100

Study Arms (1)

QUAIL-100 SIngle Ascending Dose

EXPERIMENTAL

Single doses of QUAIL-100 at 3x10\^7 to 1x10\^9CFU

Biological: QUAIL-100

Interventions

QUAIL-100BIOLOGICAL

live, attenuated bacterial therapeutic

QUAIL-100 SIngle Ascending Dose

Eligibility Criteria

Age18 Months - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Weight \>/= 10 kg
  • Have received HLA-partially matched related or unrelated donor ab-depleted hematopoietic stem cell transplant (HSCT) for high-risk malignant disease and has achieved myeloid and platelet engraftment
  • Lanksy/Karnofsky score \> 60
  • Participants of childbearing potential must agree to use contraception to prevent pregnancy

You may not qualify if:

  • Active Grade II acute graft versus host disease (aGVHD) requiring \> 0.5 mg/kg methylprednisolone or any diagnosis of Grade III/IV aGVHD
  • Significant cardiac, pulmonary, renal, hepatic, GI, neurological or immunological disease that could compromise safe participation
  • Known allergies, hypersensitivity or intolerance to both amoxicillin and gentamycin
  • Implanted medical devices with high potential for bacterial seeding, including pacemakers, artificial cardiac valves, prosthetic joints, orthopedic plates or screws, atrial appendage or inferior vena cava devices for thrombosis prevention
  • Planned anti-leukemic therapy within 21 days of planned dosing
  • Use of TNFa or PI3K inhibitors within 60 days of screening
  • Any prior investigational Listeria product including QUAIL-100
  • Live, attenuated vaccine within 4 weeks of first dose

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucille Packard Children's Hospital of Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Chevee V, Lobanovska M, Rivera-Lugo R, Guereca L, Feng Y, Anaya-Sanchez A, Garcia Castillo J, Huckins AM, Lemmens EE, Rae CS, Hardy JW, Carrington R, Kotula JW, Portnoy DA. Reprogramming Listeria monocytogenes flavin metabolism to improve its therapeutic safety profile and broaden innate T-cell activation. mBio. 2026 Feb 11;17(2):e0365225. doi: 10.1128/mbio.03652-25. Epub 2025 Dec 31.

    PMID: 41474325BACKGROUND

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeNeoplasmsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Central Study Contacts

Russell Carrington, PhD

CONTACT

888-498-6065clinical@lagunabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

March 1, 2029

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)