Solid TumorNCT07137312
Ex Vivo Expansion (ACT-X)
An observational study of Solid Tumor and Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Healthy, Malignant Solid Neoplasm
- What is being tested?
- Blood Draw and Apheresis
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male and female participants who have/had cancer or are healthy individuals who would like to contribute to cancer research efforts.
Who may be able to join
- 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
- Hemoglobin ≥10.0 g/dl
- Absolute neutrophil count (ANC) ≥1500/mm^3
- Platelet count ≥100,000/mm^3
Who cannot join
- Any of the following prior therapies:
- 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
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
Show all 11Show fewer
- History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection [e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
- Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids >10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
- NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Center Clinical Trials contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Keith Knutson, PhD
About this study
Official title: MC240903 Ex Vivo Expansion of Tumor Antigen-Specific T Cells for Adoptive T Cell Therapy
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.
- Conditions
- Solid Tumor, Healthy, Malignant Solid Neoplasm
- Being tested
- Blood Draw, Apheresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood DrawProcedure or surgery
Also called Blood sample collection, Biospecimen collection, Specimen collection
Participants 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.
ApheresisProcedure or surgery
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Blood Draw Group | Participants who elect to provide specimen via standard blood draw. Some participants may provide a specimen via blood draw one time (the "blood draw group") and then elect to provide a second optional specimen via apheresis (the "apheresis group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit. Receives: Procedure: Blood Draw; Procedure: Apheresis | |
| Apheresis Group | Participants who elect to provide specimen via apheresis. Apheresis is a procedure where blood is drawn from the 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. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit. Receives: Procedure: Blood Draw; Procedure: Apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; up to 3 years
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.
Measured: Baseline; up to 3 years
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.
Measured: Baseline; up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start16 Dec 2025
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Knutson, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137312
- Sponsor's protocol ID
- MC240903
- Other IDs
- 24-011832
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MC240903 Ex Vivo Expansion of Tumor Antigen-Specific T Cells for Adoptive T Cell Therapy
- ClinicalTrials.gov ID
- NCT07137312
- Acronym / sponsor ID
- MC240903
- Conditions
- Solid Tumor, Healthy, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Draw Group | – | Procedure: Blood Draw, Procedure: ApheresisParticipants who elect to provide specimen via standard blood draw. Some participants may provide a specimen via blood draw one time (the "blood draw group") and then elect to provide a second optional specimen via apheresis (the "apheresis group") or vice versa. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit. |
| Apheresis Group | – | Procedure: Blood Draw, Procedure: ApheresisParticipants who elect to provide specimen via apheresis. Apheresis is a procedure where blood is drawn from the 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. Thus, which specimen collection group a given participant is in may change based on patient and provider preference for a given visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female participants who have/had cancer or are healthy individuals who would like to contribute to cancer research efforts.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- Any of the following prior therapies:
- Active hematologic malignancies ≤ 3 years prior to registration
- Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
- History of active tuberculosis (TB), human immunodeficiency virus (HIV), active hepatitis B (e.g., HBsAg reactive), and/or active hepatitis C infection [e.g., Hepatitis C Virus (HCV) ribonucleic acid (RNA) qualitative is detected)
- Known history of active autoimmune disease that has required systemic treatment in the ≤14 days (i.e., with the use of disease-modifying agents, corticosteroids >10 mg daily prednisone equivalent, or other immunosuppressive drugs) prior to registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood DrawAlso: Blood sample collection, Biospecimen collection, Specimen collectionParticipants 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. | Procedure or surgery | Apheresis Group, Blood Draw Group |
| ApheresisParticipants 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. | Procedure or surgery | Apheresis Group, Blood Draw Group |
Primary outcome
Immune effector networks
Time frame: Baseline; up to 3 years
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.
Dendritic cell signaling programs
Time frame: Baseline; up to 3 years
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.
Cytokine capture methods
Time frame: Baseline; up to 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Center Clinical Trials contact
Keith Knutson, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor and Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune effector networks (time frame: Baseline; up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.