STAVs + Dendritic Cell Vaccine for Aggressive Relapsed/Refractory Leukemias

Recruiting in Palo Alto (17 mi)

Overseen by Juan C Ramos, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Juan C. Ramos, MD

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this research is to investigate whether the combination of STING-dependent Adjuvants (STAVs) and dendritic cell (DC) vaccine therapies will increase the body's ability to fight aggressive relapsed or refractory leukemias.

Research Team

Juan C Ramos, MD

Principal Investigator

University of Miami

Eligibility Criteria

Inclusion Criteria

For R/R ALL, the patient must have failed (relapsed or primary refractory) induction chemotherapy with consolidation if a suitable candidate± (i.e. ECOG 2993 or similar regimen). The patient should also have failed blinatumomab if CD19+ B-cell ALL, inotuzumab if CD22+ B-cell ALL, tyrosine kinase inhibitor if bcr-abl+, or salvage chemotherapy if available and if the patient is a suitable candidate± for these therapies.

ǂ Transplant ineligible patients are defined as those not suitable for potentially curative allogeneic stem cell transplant based on lack of disease control or remission at the time of evaluation, inadequate organ function, age, and overall health and performance status as determined by the treating physician, or patient's refusal to undergo such treatment procedure.

Adults (≥ 18 years of age) regardless of their gender and genetic background Karnofsky performance status (KPS) ≥ 50% or Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. (see Appendix B for definitions).

Exclusion Criteria

HIV infection.

Patients who have previously received allogeneic stem cell transplant are ineligible

Patients receiving cytotoxic chemotherapy within 14 days or any other investigational biological agents within 7 days prior to initiation of study therapy.

Treatment Details

Interventions

• Dendritic Cell Vaccine (Cancer Vaccine)
• STING-Dependent Activators (STAVs) Loaded Autologous Leukemic Cells (Virus Therapy)

Participant Groups

Group I: Combination STAVs and DC Vaccine Group Experimental Treatment 2 Interventions

Participants will receive STAV-loaded cells for a total of 5 doses on Days 3, 17, 31, 45 and 59. Participants will also receive up to 4 doses of dendritic vaccine on Days 10, 17, 24 and 31.

Who Is Running the Clinical Trial?

Juan C. Ramos, MD

Lead Sponsor

Trials

1