Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Laguna Biotherapeutics, Inc.
- Study ID
- NCT07573111
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Acute Leukemia
- Myelodysplastic Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Months - 39 Years
- Healthy Volunteers
- Not accepted
Interventions
- QUAIL-100 — BIOLOGICALlive, attenuated bacterial therapeutic
Study Details
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Key Dates
- First listed
- May 7, 2026
- Start date
- Aug 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 30, 2028
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: QUAIL-100 SIngle Ascending DoseSingle doses of QUAIL-100 at 3x10\^7 to 1x10\^9 CFU
Primary Outcome Measure
Incidence of treatment-emergent adverse events [ Time Frame: 12 weeks after administration of QUAIL-100 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Lucille Packard Children's Hospital of Stanford University | Palo Alto | California | 94304 | Orly Klein, MD (PRINCIPAL_INVESTIGATOR) |
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