Acute LeukemiaPhase 1NCT07573111
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
A Phase 1 study testing QUAIL-100 in people with Acute Leukemia and Myelodysplastic Syndrome, run by Laguna Biotherapeutics, Inc. at 1 site in United States.
Trial summary
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant Read more about this study
- Who is it for?
- Ages 18 months to 39 years
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndrome
- What is being tested?
- QUAIL-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 tumor necrosis factor (TNF) a or phosphatidylinositol 3-kinase (PI3K) inhibitors within 60 days of screening
- Any prior investigational Listeria product including QUAIL-100
- Live, attenuated vaccine within 4 weeks of first dose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucille Packard Children's Hospital of Stanford University
Palo Alto, California, 94304
Noor Akhter, 650-725-9709, scgt_clinical_trials_office@lists.stanford.edu
Orly Klein, MD
About this study
Official title: An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome
- Being tested
- QUAIL-100
- Keywords
- Leukemia, Myelodysplastic Syndrome (MDS), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), transplant, hematopoietic stem cell transplant, LGNA-100
- Medical subject headings
- Myelodysplastic Syndromes, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUAIL-100Biological
live, attenuated bacterial therapeutic
| Study group | Role | What they receive |
|---|---|---|
| QUAIL-100 SIngle Ascending Dose | Experimental | Single doses of QUAIL-100 at 3x10^7 to 1x10^9 CFU Receives: Biological: QUAIL-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events
Incidence of treatment-emergent adverse events
Measured: 12 weeks after administration of QUAIL-100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laguna Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573111
- Sponsor's protocol ID
- QUAIL-100-02-001
- Status last verified
- Aug 2026
- First submitted
- 1 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41474325
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, First-in-Human, Single Ascending Dose Study of QUAIL-100 in Pediatric and Young Adult Subjects With High-Risk Acute Leukemias and Myelodysplastic Syndrome Who Have Received a T-cell Receptor (TCR) αβ+ T Cell/CD-19+ B Cell-Depleted Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07573111
- Acronym / sponsor ID
- QUAIL-100-02-001
- Conditions
- Acute Leukemia, Myelodysplastic Syndrome
- Keywords
- Leukemia, Myelodysplastic Syndrome (MDS), Acute Lymphocytic Leukemia (ALL), Acute Myeloid Leukemia (AML), transplant, hematopoietic stem cell transplant, LGNA-100
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Laguna Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QUAIL-100 SIngle Ascending Dose | Experimental | Biological: QUAIL-100Single doses of QUAIL-100 at 3x10^7 to 1x10^9 CFU |
Who may qualify
- Ages
- 18 months to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUAIL-100live, attenuated bacterial therapeutic | Biological | QUAIL-100 SIngle Ascending Dose |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: 12 weeks after administration of QUAIL-100
Incidence of treatment-emergent adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 41474325Chevee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucille Packard Children's Hospital of Stanford University
Palo Alto, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QUAIL-100 in people with Acute Leukemia and Myelodysplastic Syndrome, run by Laguna Biotherapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: 12 weeks after administration of QUAIL-100). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07573111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.