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RecruitingNCT07573111Updated Aug 21, 2026

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 interventional study of QUAIL-100 in Acute Leukemia and Myelodysplastic Syndrome, sponsored by Laguna Biotherapeutics, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Months to 39 Years. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Laguna Biotherapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Months to 39 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,363 studies in Myelodysplastic Syndromes with a site in United States — 174 open to participants now, 278 under way, 17 of them phase 3. Myelodysplastic Syndromes · United States.

Planned enrollment
955th of 1,189
12 · median 35
Started
2026
with 30 others
Phase 1
384 of 1,363
56 open now
Primary completion
2028-06
later than 194 of 274 live
Registered
1,352nd of 1,363
by date

Among the 1,363 studies in Myelodysplastic Syndromes with a site in United States, this one is the 955th largest by planned enrollment of the 1,189 interventional ones that give a count, is one of 31 that started in 2026, is one of 384 in phase 1, reaches primary completion later than 194 of the 274 other live ones, and was the 1,352nd registered.

Myelodysplastic Syndromes

1,997 studies on the registry are indexed under Myelodysplastic Syndromes; 324 are open to participants now.

Browse Myelodysplastic Syndromes studies →

Open to participants now

174 of the 1,363 studies in Myelodysplastic Syndromes with a site in United States are open now. Recruiting first, the newest first:

168 more — sign in →

All 174 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 264 Myelodysplastic Syndromes studies recruiting now, 167 (63%) set no upper age limit and 70 (27%) stop at 75 or younger; 57 take children under 18; 17 take healthy volunteers.

This study: 18 Months to 39 Years · all sexes · no healthy volunteers.

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02

Study summary

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

03

Conditions studied

  • Acute Leukemia
  • Myelodysplastic Syndrome

Keywords

  • Leukemia
  • Myelodysplastic Syndrome (MDS)
  • Acute Lymphocytic Leukemia (ALL)
  • Acute Myeloid Leukemia (AML)
  • transplant
  • hematopoietic stem cell transplant
  • LGNA-100
04

Who can participate

Ages eligible
18 Months to 39 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Active Grade II acute (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, 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 Listeria product including QUAIL-100
  • Live, attenuated vaccine within 4 weeks of first dose
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

GVHD (graft-versus-host disease)

After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    QUAIL-100 SIngle Ascending Dose

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

    Biological: QUAIL-100

Interventions

  • BiologicalQUAIL-100

    live, attenuated bacterial therapeutic

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Incidence of treatment-emergent adverse events

    Time frame: 12 weeks after administration of QUAIL-100

07

Study locations

1 of 1 sites recruiting
  • Lucille Packard Children's Hospital of Stanford University
    Palo Alto, California 94304, United States
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jun 2028, 22 months later.

Of 84 industry-sponsored phase 1 interventional studies under Myelodysplastic Syndromes, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 72. This study's planned 22 months is below that.

Counting every sponsor, half of 219 studies reached it within 52 months; a quarter within 31 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2026
First posted
May 7, 2026
StartEst.
Aug 2026
Primary completionEst.
Jun 2028
CompletionEst.
Mar 2029
Last update
Aug 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07573111
Lead sponsor
Laguna Biotherapeutics, Inc.
Responsible party
Sponsor
First posted
May 7, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jun 2028 (estimated)
Completion
Mar 2029 (estimated)
Last update
Aug 21, 2026

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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