QUAIL-100 for High-Risk Blood Cancers in Young Patients
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 Months – 39
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Laguna Biotherapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for young patients with serious blood cancers who have had a stem cell transplant. Participants will receive a treatment called QUAIL-100 and will be monitored for their health after the transplant.
Are You a Good Fit for This Trial?
You may be able to join if
I weigh at least 10 kg.
I have had a stem cell transplant for high-risk cancer.
I have solid blood cell recovery after my transplant.
I have a Karnofsky score above 60.
I will use contraception if I can become pregnant.
You may not be able to join if
I have active Grade II acute graft versus host disease.
I have serious heart, lung, kidney, liver, or brain problems.
I am allergic to both amoxicillin and gentamycin.
I have an implanted device that could cause serious infections.
I have planned cancer treatment within 21 days of starting this trial.
I have taken certain medications for cancer within the last 60 days.
I have received any investigational Listeria product before.
I have had a live vaccine in the last 4 weeks.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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 childbear…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Contacts
No contact information available.
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