Ex Vivo Expansion (ACT-X)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to understand how the body's immune cells respond to a new type of vaccine (neoantigen vaccine) designed to help the immune system recognize and fight cancer. To do this, the study team will collect a research specimen from participants to study their immune cells' reactions to the neoantigen vaccine. This research will help researchers learn more about how these vaccines might work to protect or treat against cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Histologically confirmed current or previous solid malignancy or healthy individuals
Willing to provide mandatory research blood draw or apheresis per protocol
Provide written informed consent
The following laboratory values obtained ≤ 28 days prior to registration
Disqualifiers
IV antibiotic ≤2 weeks prior to apheresis
Major Surgery ≤4 weeks prior to registration
Received a live vaccine ≤30 days prior to registration
Active hematologic malignancies ≤ 3 years prior to registration
Trial population
Male and female participants who have/had cancer or are healthy individuals who would like to contribute to cancer research efforts.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Blood Draw
Procedure/SurgeryParticipants have a standard blood draw or apheresis on study. Some participants may provide a specimen via apheresis one time (the "blood draw group") and then elect to provide a second optional specimen via a standard blood draw (the "apheresis draw group") or vice versa.
Apheresis
Procedure/SurgeryParticipants have a standard blood draw or apheresis on study. Apheresis is a procedure where blood is drawn from your body, specific components like plasma, platelets, and/or white blood cells are separated out, and the rest of the blood is returned. Some participants may provide a specimen via apheresis one time (the "apheresis group") and then elect to provide a second optional specimen via a standard blood draw (the "blood draw group") or vice versa.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Blood Draw Group2 interventions
Group B: Apheresis Group2 interventions
Trial outcomes
Primary outcomes
1
Immune effector networks
Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify immune effector networks that accelerate ex vivo expansion of antigen-specific memory precursor T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.
Time frame
Baseline; up to 3 years2
Dendritic cell signaling programs
Specimen samples obtained by blood draw and/or apheresis will be analyzed to define dendritic cell signaling programs that foster generation of polyfunctional, high avidity antigen-specific T cells capable of recognizing naturally processed tumor antigen. All tests will be two sided with a p\<0.05 being considered as statistically significant.
Time frame
Baseline; up to 3 years3
Cytokine capture methods
Specimen samples obtained by blood draw and/or apheresis will be analyzed to identify cytokine capture methods for isolation of antigen-specific T cells. All tests will be two sided with a p\<0.05 being considered as statistically significant.
Time frame
Baseline; up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov