QUAIL-100 for Acute Leukemia

Overseen By Russell Carrington, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Laguna Biotherapeutics, Inc.

Must not be taking: TNFa inhibitors, PI3K inhibitors

Disqualifiers: Significant cardiac, pulmonary, renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

Inclusion Criteria

Weight \\/= 10 kg

Participants of childbearing potential must agree to use contraception to prevent pregnancy

I had a partially matched donor stem cell transplant and my blood counts have recovered.

Exclusion Criteria

I have used TNFa or PI3K inhibitor medicines in the past 60 days.

Any prior investigational Listeria product including QUAIL-100

I have not received a live vaccine in the past 4 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending dose of QUAIL-100

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• QUAIL-100

How Is the Trial Designed?

Group I: QUAIL-100 SIngle Ascending Dose Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Laguna Biotherapeutics, Inc.

Lead Sponsor