Safety Trial of STING-dependent Activators and Stimulated Dendritic Cells for Aggressive Relapsed/Refractory Leukemias
NCT05321940 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2023-12-04
Summary
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.
Conditions
- Refractory Leukemia
- Relapsed Leukemia
- Acute Myelogenous Leukemia
- Acute Lymphoblastic Leukemia
- Adult T-Cell Leukemia/Lymphoma
Interventions
- BIOLOGICAL
-
STING-Dependent Activators (STAVs) Loaded Autologous Leukemic Cells
Autologous human ultraviolet (UV)-irradiated (dead) leukemia cells loaded with STAVs administered via intravenous injection. Each treatment will administer 5 ml via syringe.
- BIOLOGICAL
-
Dendritic Cell Vaccine
15-20 Million mature dendritic cells per dose administered via intravenous injection.
Sponsors & Collaborators
-
Juan C. Ramos, MD
lead OTHER
Principal Investigators
-
Juan C Ramos, MD · University of Miami
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-30
- Primary Completion
- 2025-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
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