Head and Neck Cancers- Squamous CellPhase 1NCT06736379
Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer
A Phase 1 study testing VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection), Pembrolizumab (KEYTRUDA®) and VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection) in people with Head and Neck Cancers- Squamous Cell and Head and Neck Cancer, run by VLP Therapeutics at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers- Squamous Cell, Head and Neck Cancer, Solid Tumors
- What is being tested?
- VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection), Pembrolizumab (KEYTRUDA®) and VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2025to 30 Dec 2027
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:
- Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.
- Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.
- Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).
- Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).
- Patients with activating EGFR mutation or ALK rearrangement which is expected to be responsive to available tyrosine kinase inhibitor therapy, therefore these subjects must have been previously treated with an applicable tyrosine kinase inhibitor.
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- OR Cohort C - Patients with at least 1 measurable resectable lesion clinical stage I-IVb (cT1-4, N0-3) (AJCC, 8th Edition) (Amin, 2017), Histologically or cytologically confirmed HNSCC. Scheduled to undergo tumor surgical resection of the primary tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1, and adequate bone marrow and organ function.
- Primary tumors should be amenable to intratumoral (IT) injection >1 cm diameter. This will be determined by the Protocol Director, or the surgeon involved.
- Subjects with either a local recurrence or a new primary tumor will be allowed.
- Age ≥ 18 years.
- Have acceptable organ and marrow function defined as follows:
- Absolute neutrophil count ≥ 1,500/mcL Platelets ≥ 100,000/mcL Hemoglobin ≥ 8.0 g/dL (Note: use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable) Total bilirubin ≤2x institutional upper limit of normal (ULN) AST(SGOT) or ALT(SGPT) ≤ 3.0x institutional ULN
- Ability to understand and the willingness to provide written informed consent.
- Life expectancy > 12 weeks (about 3 months).
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Who cannot join
- Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.
- Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
- Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.
- Participation in another clinical study with an investigational product during the last 30 days.
- Uncontrolled intercurrent illness including, that do not respond to active medical intervention.
- Current or prior use of immunosuppressive medication within 28 days before the first dose of injection, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid.
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- If applicable: Women who are breastfeeding.
- History of allogenic organ transplant that requires use of immunosuppressives.
- Subject has active or uncontrolled infection including known HIV infection or known chronic hepatitis B or C.
- Any condition that, in the investigator's opinion, would interfere with evaluation of study treatment or interpretation of patient safety or study results.
- Uncontrolled intercurrent illness including those that do not respond to active medical intervention.
- Any contraindication to the use of known history of hypersensitivity to any immune therapy's drugs.
- Subjects must not have received any live vaccine within 28 days prior to the first dose of study treatment.
- Active autoimmune disease that requires systemic therapy, in the Investigator's opinion, may increase the risk of study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 34305
Clinical Research Coordinator, 650-725-9333, tpark22@stanford.edu
Fred M Baik, MD
About this study
Official title: Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer
The goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:
The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)
The tumor response to IT injections of VLPONC-01
The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment
Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.
Read the detailed description
The study is an Open label, Phase I study to determine the safety of IT injected VLPONC-01 as a therapeutic agent in subjects with non-resectable and resectable Head and Neck Cancer Squamous Cell Carcinomas (HCSCC), and secondarily to assess pathologic response and radiological response (assessed by RECIST 1.1 criteria) in the primary tumor and regional lymph nodes. Researchers also will explore tumor microenvironment changes in cytokine levels and cellular responses.
There will be three distinct cohorts enrolling sequentially:
Cohort A: Researchers will enroll unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery who will receive four doses of VLPONC-01.
Cohort C: Researchers will enroll HCSCC patients scheduled for tumor resection surgery who will receive four doses of VLPONC-1 and two doses of neoadjuvant pembrolizumab or only two doses of neoadjuvant pembrolizumab prior to tumor resection surgery.
- Conditions
- Head and Neck Cancers- Squamous Cell, Head and Neck Cancer, Solid Tumors, HNSCC, SCC - Squamous Cell Carcinoma, SCCHN
- Being tested
- VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection), Pembrolizumab (KEYTRUDA®), VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)
- Keywords
- Virus-like particle, VLP, IL-12, Interleukin 12, Intratumoral, VRP, Viral Replicon Particle, saRNA, VRP-encapsulated, IT injection, pembrolizumab, anti-PD-1, tumor resection surgery, tumor resection, Self-amplifying RNA, Multiple inoculations directly into the tumor, Keytruda, viral particles per injection, viral particles, macrophage
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)Biological
Also called VLPONC-01, IL-12 saRNA, VRP-IL-12
Weekly IT injections of 1 x 10^9 viral particles of VLPONC-01
Pembrolizumab (KEYTRUDA®)Drug
Also called Pembrolizumab
200mg twice 3 weeks apart IV
VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)Biological
Also called VLPONC-01, VRP-IL-12, IL-12 saRNA
Weekly IT injections of 3 x 10^8 viral particles of VLPONC-01
| Study group | Role | What they receive |
|---|---|---|
| Cohort A (1 x 10^9 viral particles per injection) | Experimental | Recurrent or Metastatic Head and Neck Cancer not scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly, with an additional follow-up safety visit 30 and 90 days post the final injection. Receives: Biological: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection) |
| Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab) | Experimental | Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment. Receives: Biological: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection); Drug: Pembrolizumab (KEYTRUDA®) |
| Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab) | Experimental | Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery follow-up safety visit 30 days post-surgery and 90 days post final treatment. Receives: Drug: Pembrolizumab (KEYTRUDA®); Biological: VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection) |
| Cohort C - Pembrolizumab only | Experimental | Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment. Receives: Drug: Pembrolizumab (KEYTRUDA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To assess the safety and tolerability of VLPONC-01. Safety will be based on the occurrence of any grade 3 or higher drug-related adverse events from the VLPONC-01 injections for non-surgery patients and any grade 3 or higher drug-related adverse events that result in a delay to tumor resection surgery.
Measured: First injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort C)
Secondary outcomes (4)
Levels of circulating IL-12
To assess the circulating blood levels of IL-12 after VLPONC-01 treatment compared to baseline to determine the occurrence and safety profile of potential systemic inflammatory responses.
Measured: First injection to 30-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort C)
VLPONC-01 levels in tumor tissue
To detect levels of VLPONC-01 RNA in surgically resected tissue.
Measured: First injection to tumor resection surgery
Radiological Tumor Response
To assess the primary tumor response by RECIST.
Measured: First injection to tumor resection surgery (up to 3 months)
Pathological Tumor Response
To assess the primary tumor response by pathological analysis.
Measured: First injection to tumor resection surgery (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start13 May 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancers- Squamous CellStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose de-escalation Model
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VLP Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Fred M Baik, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736379
- Sponsor's protocol ID
- VLPONC-01
- Other IDs
- SYNERNA-01
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Intratumoral Injections of VLPONC-01 in Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT06736379
- Acronym / sponsor ID
- VLPONC-01
- Conditions
- Head and Neck Cancers- Squamous Cell, Head and Neck Cancer, Solid Tumors, HNSCC, SCC - Squamous Cell Carcinoma, SCCHN
- Keywords
- Virus-like particle, VLP, IL-12, Interleukin 12, Intratumoral, VRP, Viral Replicon Particle, saRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- VLP TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 13 May 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Dec 2024 (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 goal of this clinical trial is to assess the safety and tolerability of a virus replicon particle (VRP) encapsulated saRNA encoding IL-12 when injected into in head and neck cancer patients. The main questions being addressed are:
The safety and tolerability of intratumoral (IT) injections of VRP-encapsulated saRNA encoding IL-12 (VLPONC-01)
The tumor response to IT injections of VLPONC-01
The tumor response due to the combination of IT injections of VLPONC-01 and system IV administration of neoadjuvant pembrolizumab (anti-PD-1) treatment
Researchers will compare neoadjuvant pembrolizumab alone to the combination therapy to see if the combination enhances tumor responses.
Detailed description
The study is an Open label, Phase I study to determine the safety of IT injected VLPONC-01 as a therapeutic agent in subjects with non-resectable and resectable Head and Neck Cancer Squamous Cell Carcinomas (HCSCC), and secondarily to assess pathologic response and radiological response (assessed by RECIST 1.1 criteria) in the primary tumor and regional lymph nodes. Researchers also will explore tumor microenvironment changes in cytokine levels and cellular responses.
There will be three distinct cohorts enrolling sequentially:
Cohort A: Researchers will enroll unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery who will receive four doses of VLPONC-01.
Cohort C: Researchers will enroll HCSCC patients scheduled for tumor resection surgery who will receive four doses of VLPONC-1 and two doses of neoadjuvant pembrolizumab or only two doses of neoadjuvant pembrolizumab prior to tumor resection surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Dose de-escalation Model
| Arm | Type | Receives |
|---|---|---|
| Cohort A (1 x 10^9 viral particles per injection) | Experimental | Biological: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)Recurrent or Metastatic Head and Neck Cancer not scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly, with an additional follow-up safety visit 30 and 90 days post the final injection. |
| Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab) | Experimental | Biological: VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection), Drug: Pembrolizumab (KEYTRUDA®)Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment. |
| Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab) | Experimental | Drug: Pembrolizumab (KEYTRUDA®), Biological: VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 4 doses VLPONC-01 administered IT once weekly and 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery follow-up safety visit 30 days post-surgery and 90 days post final treatment. |
| Cohort C - Pembrolizumab only | Experimental | Drug: Pembrolizumab (KEYTRUDA®)Head and Neck Squamous Cell Carcinoma Patients scheduled for tumor resection surgery, 2 doses of 200mg neoadjuvant Pembrolizumab IV 3 weeks apart prior to tumor resection surgery, follow-up safety visit 30 days post-surgery and 90 days post final treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Cohort A - Unresectable or recurrent/metastatic head and neck cancer with at least 1 injectable tumor not scheduled for tumor resection surgery. With one the following prior treatments:
- Subjects must have received a platinum containing chemotherapy regimen, 5-Fluorouracil chemotherapy, taxane based chemotherapy, cetuximab or gemcitabine for treatment of primary tumor in locally advanced, or metastatic settings.
- Subjects must have received an anti-PD-1/ PD-L1 as monotherapy or in combination with chemotherapy.
- Subjects must have progressed following therapy with at least one PD-1 or PD-L1 checkpoint inhibitor (regardless of PD-L1 expression status).
- Prior progression on a PD-1 or PD-L1 checkpoint inhibitor should be unequivocal; progression that occurs within the first 8 weeks of treatment on these agents should be confirmed with a second CT at least 4 weeks apart (to exclude pseudo-progression).
Key exclusion criteria (14 listed)
- Tumors which are not feasible for injections include high risk lesions that are near vital organs or important neurovascular structures, as determined by the Protocol Director or involved surgeon.
- Women of childbearing potential must have a negative serum β-hCG pregnancy test within 7 days prior to the administration of the first study treatment and/or urine pregnancy 48 hours prior to the administration of the first study treatment. Both sexually active women of childbearing potential and males (and their female partners) patients must agree to use two methods of effective contraception, one of them being a barrier method, or to abstain from sexual activity during the study and for at least 6 months after last dose of study drugs.
- Patients expected to receive other anti-cancer medication such as, chemotherapy, immunotherapy, biologic therapy, targeted therapy, monoclonal antibodies, hormonal therapy (other than leuprolide or other GnRH agonists) prior to surgery and where all acute toxicity of prior treatments have not resolved.
- Participation in another clinical study with an investigational product during the last 30 days.
- Uncontrolled intercurrent illness including, that do not respond to active medical intervention.
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 |
|---|---|---|
| VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection)Also: VLPONC-01, IL-12 saRNA, VRP-IL-12Weekly IT injections of 1 x 10^9 viral particles of VLPONC-01 | Biological | Cohort A (1 x 10^9 viral particles per injection), Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab) |
| Pembrolizumab (KEYTRUDA®)Also: Pembrolizumab200mg twice 3 weeks apart IV | Drug | Cohort C - Group 1 (1 x 10^9 viral particles per injection plus Pembrolizumab), Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab), Cohort C - Pembrolizumab only |
| VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection)Also: VLPONC-01, VRP-IL-12, IL-12 saRNAWeekly IT injections of 3 x 10^8 viral particles of VLPONC-01 | Biological | Cohort C - Group 2 (3 x 10^8 viral particles per injection plus Pembrolizumab) |
Primary outcome
Safety and tolerability
Time frame: First injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort C)
To assess the safety and tolerability of VLPONC-01. Safety will be based on the occurrence of any grade 3 or higher drug-related adverse events from the VLPONC-01 injections for non-surgery patients and any grade 3 or higher drug-related adverse events that result in a delay to tumor resection surgery.
4 secondary outcomes
Levels of circulating IL-12
Time frame: First injection to 30-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort C)
VLPONC-01 levels in tumor tissue
Time frame: First injection to tumor resection surgery
Radiological Tumor Response
Time frame: First injection to tumor resection surgery (up to 3 months)
Pathological Tumor Response
Time frame: First injection to tumor resection surgery (up to 3 months)
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 21 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Fred M Baik, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRP-encapsulated saRNA encoding IL-12 (1 x 10^9 viral particles per injection), Pembrolizumab (KEYTRUDA®) and VRP-encapsulated saRNA encoding IL-12 (3 x 10^8 viral particles per injection) in people with Head and Neck Cancers- Squamous Cell and Head and Neck Cancer, run by VLP Therapeutics 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 16 inclusion and 14 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 21 Sep 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Research Coordinator (650-725-9333, tpark22@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (time frame: First injection to 90-day follow-up visit post-final injection (Cohort A) or post-surgery (Cohort C)). 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 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.