Squamous Cell Carcinoma of Head and NeckPhase 1NCT07898124
TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma
A Phase 1 study testing TMV Vaccine and Toripalimab-tpzi in people with Squamous Cell Carcinoma of Head and Neck and Squamous Cell Carcinoma of Head and Neck (SCCHN), run by Metaclipse Therapeutics Corporation at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of Head and Neck (SCCHN), HNSCC
- What is being tested?
- TMV Vaccine and Toripalimab-tpzi
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 28 Feb 2031
- 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
- Age 18 years or older.
- Recurrent, histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to curative salvage surgery. EBV- and HPV/p16-positive and -negative tumors are allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, sinonasal carcinoma, and cancer of unknown primary (squamous cell carcinoma only) are allowed.
- Oropharyngeal tumors must have EBV and p16 or HPV testing done.
- Tumor tissue must be available and banked (below -70°C) at the time of salvage surgery (Phase 1a) or biopsy (Phase 1b), with the tissue collection informed consent signed.
- Enough tissue collected at salvage surgery (Phase 1a) or biopsy (Phase 1b) to make at least 3 doses of vaccine: resectable tumor tissue weighing at least 1 gram (approximately 0.5 to 3 cm³) with adequate cellularity (greater than 40% viable tumor cellularity), as assessed by pathology using the corresponding biopsy or surgical specimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- Phase 1b only: Tumor must be PD-L1 positive (combined positive score [CPS] of 1 or higher) by IHC (22C3), performed in the MD Anderson CLIA-certified laboratory.
- Phase 1b only: Measurable disease per RECIST 1.1.
- Adequate hematologic function:
- Absolute neutrophil count ≥ 1,500 cells/µL
- Platelets ≥ 100,000/µL
- Hemoglobin ≥ 9.0 g/dL (red blood cell transfusion allowed)
- Adequate hepatic function:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST and ALT ≤ 2.5 x ULN
- Albumin ≥ 3.0 g/dL
- Adequate renal function:
- Serum creatinine ≤ 1.5 x ULN
- Creatinine clearance ≥ 50 mL/min, calculated using the Cockcroft-Gault formula
- INR ≤ 1.5. Anticoagulation is allowed. Patients receiving low molecular weight heparin on a stable therapeutic dose for more than 2 weeks, or with a factor Xa level < 1.1 U/mL, are allowed.
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Able to understand and willing to sign written informed consent documents.
- Females of childbearing potential (FCBP) must agree to use 2 acceptable methods of contraception, 1 from Category A and 1 from Category B, during study treatment and for 3 months after the last dose, or agree to remain abstinent from heterosexual intercourse when this is consistent with their preferred and usual lifestyle.
- Category A (highly effective methods): hormonal contraceptives (oral, injectable, transdermal, or implantable); intrauterine device (IUD) or intrauterine hormone-releasing system; vasectomized partner (with confirmed azoospermia) as the sole sexual partner
- Category B (barrier methods): male condom; female condom; diaphragm or cervical cap used with spermicide
- An FCBP is a sexually mature woman who has not had a hysterectomy or bilateral oophorectomy, or who has not been naturally postmenopausal for at least 24 consecutive months (has had menses during the preceding 24 consecutive months).
- Males who are sexually active with an FCBP must agree to use an effective method of contraception (for example, a male condom) during study treatment and for 3 months after the last dose, in addition to their partner's contraception, or agree to remain abstinent from heterosexual intercourse when this is consistent with their preferred and usual lifestyle.
- Females of childbearing potential must have a negative serum pregnancy test at study entry.
Who cannot join
- Nasopharyngeal carcinoma, salivary gland tumors, or non-squamous cell histology of the head and neck.
- Other malignancies within the past 5 years, other than those specified in the inclusion criteria. Patients with prior malignancies, including pelvic cancer, are eligible if disease free for more than 5 years. Patients with prior in situ carcinomas are eligible if there was complete removal.
- Not enough tissue collected at surgery (Phase 1a) or biopsy (Phase 1b) for the planned 3 doses (resectable tumor tissue weighing less than 1.0 gram).
- Treatment with chronic immunosuppressants (for example, cyclosporine following transplantation).
- Prior organ allograft or allogeneic bone marrow transplantation.
- Active, known, or suspected autoimmune disease. Patients with vitiligo, psoriasis not requiring systemic treatment, alopecia, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring only hormone replacement, or conditions not expected to recur in the absence of an external trigger are permitted.
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- A condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease.
- Uncontrolled intercurrent illness including, but not limited to, HIV-positive patients receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Other medications, severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities that may increase the risk of study participation or study drug administration, or may interfere with interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for the study.
- Clinical evidence of bleeding diathesis or coagulopathy.
- Active bacterial or fungal infection requiring systemic treatment within 7 days of treatment.
- Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.
- Non-oncology vaccines within 28 days before planned treatment.
- Failure to recover from Grade 3 or 4 toxicity from previous treatment.
- Prior immuno-oncology therapy within 6 months of study enrollment, including experimental anti-tumor vaccines; any agent targeting T cell co-stimulation or checkpoint pathways, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies (including ipilimumab); or other medicines specifically targeting T cell co-stimulation or checkpoint pathways.
- Ongoing or planned systemic anti-cancer therapy or radiation therapy. The last cycle of cytotoxic therapy must be at least 21 days, and the last dose of radiotherapy at least 14 days, before the first dose of TMV vaccine.
- Pregnant or breastfeeding.
- Positive pregnancy test at enrollment or before study drug administration.
- Prisoners as defined by 45 CFR 46.303(c).
- Phase 1b only: History of severe hypersensitivity reaction to any monoclonal antibody.
- Phase 1b only: History of hypersensitivity to toripalimab-tpzi (LOQTORZI) or any of its excipients.
- Phase 1b only: Prior Grade 4 immune-related adverse events (irAEs) from previous immune checkpoint inhibitor therapy. Patients with Grade 2 or 3 toxicity from prior checkpoint inhibitor therapy may enroll if the toxicity has resolved to Grade 1 or lower.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raja Nicholas, PhD contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Israel Glover, 832-748-6597, IKGlover@MDAnderson.org
Neal Akhave, MD
About this study
Official title: Phase 1 Study of TMV Vaccine Alone or TMV Vaccine Plus Toripalimab-tpzi in Loco-Regionally Recurrent Head and Neck Squamous Cell Carcinoma
The goal of this clinical trial is to learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who are planning to have surgery to remove it. The study will also test the vaccine together with toripalimab-tpzi, an approved immunotherapy drug.
The TMV vaccine is made from each participant's own tumor tissue. Small particles taken from the surface of the tumor cells have 2 immune-boosting proteins added to them, to help the immune system recognize and attack the cancer.
Read more
The main questions it aims to answer are:
- Is the TMV vaccine safe, and what medical problems do participants have after receiving it?
- What is the best dose of the TMV vaccine to use in future studies?
- Is the TMV vaccine safe when given together with toripalimab-tpzi before and after surgery?
The study has 2 parts.
In Part 1 (Phase 1a), participants will:
- Have tumor tissue collected during their planned surgery, which is used to make their personal vaccine
- Receive the vaccine as small injections into the skin every 2 weeks for 3 doses, starting after they recover from surgery
- Visit the clinic about once a week for 8 weeks for checkups, blood tests, and safety monitoring
- Have scans every 3 months and be followed for up to 3 years
The first participants will receive the lowest dose. Later groups will receive higher doses only if the lower dose is found to be safe.
In Part 2 (Phase 1b), participants whose tumors test positive for a marker called PD-L1 will:
- Have a biopsy to collect tumor tissue for their personal vaccine
- Before surgery, receive 2 doses of the vaccine and up to 2 doses of toripalimab-tpzi through a vein
- After surgery, receive 1 more dose of the vaccine and continue toripalimab-tpzi every 3 weeks for up to 1 year
- Have regular checkups, blood tests, and scans, and be followed for up to 3 years
Researchers will also study blood and tumor samples to learn how the immune system responds to the vaccine.
Read the detailed description
This is a first-in-human, single-center, open-label Phase 1 study of an autologous tumor membrane vesicle (TMV) vaccine, alone and in combination with toripalimab-tpzi, in adults with loco-regionally recurrent head and neck squamous cell carcinoma (HNSCC) who are candidates for salvage surgery.
The TMV vaccine is prepared from each participant's resected or biopsied tumor tissue. Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors, so that tumor antigens and immune-stimulating signals are delivered together at the vaccination site.
Phase 1a is a dose escalation of TMV vaccine monotherapy given as adjuvant therapy after salvage surgery. Three dose levels (0.25 mg, 0.5 mg, and 1.0 mg) are administered intradermally every 2 weeks for 3 doses. Up to 6 participants are enrolled at each dose level, and enrollment of the first 2 participants at each dose level is staggered by at least 28 days. Safety and immune stimulating activity are reviewed together to identify the optimal biological dose (OBD).
Phase 1b evaluates the TMV vaccine at the OBD in combination with toripalimab-tpzi in participants with PD-L1-positive tumors, using a combined neoadjuvant and post-operative adjuvant approach. Participants receive 2 neoadjuvant vaccine doses (every 2 weeks) and up to 2 doses of toripalimab-tpzi (every 3 weeks) before surgery, followed by 1 adjuvant vaccine dose and toripalimab-tpzi every 3 weeks for up to 1 year or until disease progression.
Participants are followed for survival for up to 3 years after treatment initiation.
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of Head and Neck (SCCHN), HNSCC, Neoplasm Recurrence, Local, Recurrent Head and Neck Squamous Cell Carcinoma
- Being tested
- TMV Vaccine, Toripalimab-tpzi
- Keywords
- TMV vaccine, tumor membrane vesicle, personalized cancer vaccine, autologous cancer vaccine, toripalimab-tpzi, LOQTORZI, anti-PD-1, immune checkpoint inhibitor, salvage surgery, adjuvant, neoadjuvant immunotherapy, HNSCC, oral cavity cancer, oropharyngeal cancer, laryngeal cancer, hypopharyngeal cancer, PD-L1, IL-12, B7-1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Neoplasm Recurrence, Local, Mouth Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Hypopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMV VaccineBiological
Also called Tumor Membrane Vesicle Vaccine, MTC-Vaccine-P, Membrex
Autologous, personalized tumor membrane vesicle (TMV) vaccine prepared from the participant's own tumor tissue, collected at salvage surgery (Phase 1a) or by biopsy (Phase 1b). Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors. Administered by intradermal injection at dose levels of 0.25 mg, 0.5 mg, or 1.0 mg in Phase 1a, and at the optimal biological dose identified in Phase 1a for Phase 1b.
Toripalimab-tpziBiological
Also called LOQTORZI, JS001
Anti-PD-1 monoclonal antibody administered at 240 mg by intravenous infusion every 3 weeks, for up to 2 doses before salvage surgery and then for up to 1 year after surgery or until disease progression (Phase 1b only).
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a Dose Level 1: TMV Vaccine 0.25 mg | Experimental | Participants receive TMV vaccine 0.25 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. Receives: Biological: TMV Vaccine |
| Phase 1a Dose Level 2: TMV Vaccine 0.5 mg | Experimental | Participants receive TMV vaccine 0.5 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. Receives: Biological: TMV Vaccine |
| Phase 1a Dose Level 3: TMV Vaccine 1.0 mg | Experimental | Participants receive TMV vaccine 1.0 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. Receives: Biological: TMV Vaccine |
| Phase 1b: TMV Vaccine + Toripalimab-tpzi | Experimental | Participants with PD-L1-positive tumors (CPS of 1 or higher) receive TMV vaccine at the optimal biological dose identified in Phase 1a, combined with toripalimab-tpzi. Before salvage surgery (neoadjuvant): TMV vaccine by intradermal injection every 2 weeks for 2 doses and toripalimab-tpzi 240 mg IV every 3 weeks for up to 2 doses. After surgery (adjuvant): 1 dose of TMV vaccine 3 weeks after surgery and toripalimab-tpzi 240 mg IV every 3 weeks for up to 1 year or until disease progression. Receives: Biological: TMV Vaccine; Biological: Toripalimab-tpzi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a
A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, except Grade 3 injection site reactions adequately controlled with medical treatment. Reported by dose level.
Measured: From first dose through 3 weeks after the last vaccine dose (7 weeks)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1a
TEAEs and SAEs graded by severity per NCI CTCAE v6.0, reported by dose level.
Measured: Frame: From first dose through 30 days after the last vaccine dose (approximately 8 weeks)
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone
RP2D of TMV vaccine monotherapy, selected based on the totality of safety, tolerability, and immunogenicity data across Phase 1a dose levels.
Measured: From first dose through 3 weeks after the last vaccine dose (7 weeks)
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, in participants receiving TMV vaccine plus toripalimab-tpzi.
Measured: From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b
TEAEs and SAEs graded by severity per NCI CTCAE v5.0.
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
Number of Participants With Immune-Related Adverse Events (irAEs) Attributable to Toripalimab-tpzi in Phase 1b
Immune-related adverse events attributed to toripalimab-tpzi, graded by severity per NCI CTCAE v5.0.
Measured: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Plus Toripalimab-tpzi
RP2D of TMV vaccine in combination with toripalimab-tpzi, selected based on the totality of safety, tolerability, and immunogenicity data.
Measured: From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months)
Secondary outcomes (9)
Change From Baseline in T Cell Activation and Phenotype in Peripheral Blood
Activation status and phenotype of T cell subsets in peripheral blood mononuclear cells (PBMCs), measured by flow cytometry, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Measured: Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6)
Change From Baseline in Plasma Cytokine and Chemokine Levels
Plasma cytokine and chemokine biomarkers measured in peripheral blood in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Measured: Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6)
Change in Percentage of Viable Tumor Cells From Baseline Biopsy to Surgical Resection in Phase 1b
Pathologic response to neoadjuvant TMV vaccine plus toripalimab-tpzi, measured as the change in viable tumor cell percentage from the pre-treatment biopsy to the resected specimen.
Measured: From pre-treatment biopsy to surgical resection (approximately 10 weeks)
Major Pathologic Response (MPR) Rate in Phase 1b
Percentage of participants with 10% or fewer viable tumor cells in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi.
Measured: At surgical resection (approximately 10 weeks after biopsy)
Pathologic Complete Response (pCR) Rate in Phase 1b
Percentage of participants with no viable tumor cells (0%) in the resected specimen after neoadjuvant TMV vaccine plus toripalimab-tpzi.
Measured: At surgical resection (approximately 10 weeks after biopsy)
Objective Response Rate (ORR) per RECIST v1.1 in Phase 1b
Percentage of participants with a complete or partial response per RECIST v1.1 on the restaging scan before surgery.
Measured: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Disease Control Rate (DCR) per RECIST v1.1 in Phase 1b
Percentage of participants with a complete response, partial response, or stable disease per RECIST v1.1 on the restaging scan before surgery.
Measured: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Progression-Free Survival (PFS)
Time from treatment initiation to first documented disease recurrence or death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Measured: Up to 3 years
Overall Survival (OS)
Time from treatment initiation to death from any cause, in participants receiving TMV vaccine alone (Phase 1a) or TMV vaccine plus toripalimab-tpzi (Phase 1b).
Measured: 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 posted27 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion28 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metaclipse Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Periasamy Selvaraj, PhD, Study director, Metaclipse TherapeuticsMichael Coleman, PhD, Study director, Metaclipse TherapeuticsChristopher Pack, PhD, Study director, Metaclipse TherapeuticsKristen Jacobsen, PhD, Study director, Metaclipse Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898124
- Sponsor's protocol ID
- MTC-004
- Status last verified
- Oct 2026
- First submitted
- 4 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers. Study results may be published in aggregate in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of TMV Vaccine Alone or TMV Vaccine Plus Toripalimab-tpzi in Loco-Regionally Recurrent Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07898124
- Acronym / sponsor ID
- MTC-004
- Conditions
- Squamous Cell Carcinoma of Head and Neck, Squamous Cell Carcinoma of Head and Neck (SCCHN), HNSCC, Neoplasm Recurrence, Local, Recurrent Head and Neck Squamous Cell Carcinoma
- Keywords
- TMV vaccine, tumor membrane vesicle, personalized cancer vaccine, autologous cancer vaccine, toripalimab-tpzi, LOQTORZI, anti-PD-1, immune checkpoint inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Metaclipse Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 28 Feb 2031 (estimated)
- First posted
- 27 Oct 2026 (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 learn if an experimental, personalized cancer vaccine called TMV vaccine is safe and to find the best dose to study in future trials. The study includes adults with head and neck squamous cell carcinoma that has come back in or near the same area after earlier treatment, and who are planning to have surgery to remove it. The study will also test the vaccine together with toripalimab-tpzi, an approved immunotherapy drug.
The TMV vaccine is made from each participant's own tumor tissue. Small particles taken from the surface of the tumor cells have 2 immune-boosting proteins added to them, to help the immune system recognize and attack the cancer.
The main questions it aims to answer are:
- Is the TMV vaccine safe, and what medical problems do participants have after receiving it?
- What is the best dose of the TMV vaccine to use in future studies?
- Is the TMV vaccine safe when given together with toripalimab-tpzi before and after surgery?
The study has 2 parts.
In Part 1 (Phase 1a), participants will:
- Have tumor tissue collected during their planned surgery, which is used to make their personal vaccine
- Receive the vaccine as small injections into the skin every 2 weeks for 3 doses, starting after they recover from surgery
- Visit the clinic about once a week for 8 weeks for checkups, blood tests, and safety monitoring
- Have scans every 3 months and be followed for up to 3 years
The first participants will receive the lowest dose. Later groups will receive higher doses only if the lower dose is found to be safe.
In Part 2 (Phase 1b), participants whose tumors test positive for a marker called PD-L1 will:
- Have a biopsy to collect tumor tissue for their personal vaccine
- Before surgery, receive 2 doses of the vaccine and up to 2 doses of toripalimab-tpzi through a vein
- After surgery, receive 1 more dose of the vaccine and continue toripalimab-tpzi every 3 weeks for up to 1 year
- Have regular checkups, blood tests, and scans, and be followed for up to 3 years
Researchers will also study blood and tumor samples to learn how the immune system responds to the vaccine.
Detailed description
This is a first-in-human, single-center, open-label Phase 1 study of an autologous tumor membrane vesicle (TMV) vaccine, alone and in combination with toripalimab-tpzi, in adults with loco-regionally recurrent head and neck squamous cell carcinoma (HNSCC) who are candidates for salvage surgery.
The TMV vaccine is prepared from each participant's resected or biopsied tumor tissue. Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors, so that tumor antigens and immune-stimulating signals are delivered together at the vaccination site.
Phase 1a is a dose escalation of TMV vaccine monotherapy given as adjuvant therapy after salvage surgery. Three dose levels (0.25 mg, 0.5 mg, and 1.0 mg) are administered intradermally every 2 weeks for 3 doses. Up to 6 participants are enrolled at each dose level, and enrollment of the first 2 participants at each dose level is staggered by at least 28 days. Safety and immune stimulating activity are reviewed together to identify the optimal biological dose (OBD).
Phase 1b evaluates the TMV vaccine at the OBD in combination with toripalimab-tpzi in participants with PD-L1-positive tumors, using a combined neoadjuvant and post-operative adjuvant approach. Participants receive 2 neoadjuvant vaccine doses (every 2 weeks) and up to 2 doses of toripalimab-tpzi (every 3 weeks) before surgery, followed by 1 adjuvant vaccine dose and toripalimab-tpzi every 3 weeks for up to 1 year or until disease progression.
Participants are followed for survival for up to 3 years after treatment initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1a Dose Level 1: TMV Vaccine 0.25 mg | Experimental | Biological: TMV VaccineParticipants receive TMV vaccine 0.25 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. |
| Phase 1a Dose Level 2: TMV Vaccine 0.5 mg | Experimental | Biological: TMV VaccineParticipants receive TMV vaccine 0.5 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. |
| Phase 1a Dose Level 3: TMV Vaccine 1.0 mg | Experimental | Biological: TMV VaccineParticipants receive TMV vaccine 1.0 mg by intradermal injection every 2 weeks for 3 doses (Weeks 0, 2, and 4) as adjuvant therapy after salvage surgery. |
| Phase 1b: TMV Vaccine + Toripalimab-tpzi | Experimental | Biological: TMV Vaccine, Biological: Toripalimab-tpziParticipants with PD-L1-positive tumors (CPS of 1 or higher) receive TMV vaccine at the optimal biological dose identified in Phase 1a, combined with toripalimab-tpzi. Before salvage surgery (neoadjuvant): TMV vaccine by intradermal injection every 2 weeks for 2 doses and toripalimab-tpzi 240 mg IV every 3 weeks for up to 2 doses. After surgery (adjuvant): 1 dose of TMV vaccine 3 weeks after surgery and toripalimab-tpzi 240 mg IV every 3 weeks for up to 1 year or until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Age 18 years or older.
- Recurrent, histologically proven squamous cell carcinoma of the head and neck (HNSCC), amenable to curative salvage surgery. EBV- and HPV/p16-positive and -negative tumors are allowed. Squamous cell carcinoma of the oral cavity, larynx, hypopharynx, oropharynx, sinonasal carcinoma, and cancer of unknown primary (squamous cell carcinoma only) are allowed.
- Oropharyngeal tumors must have EBV and p16 or HPV testing done.
- Tumor tissue must be available and banked (below -70°C) at the time of salvage surgery (Phase 1a) or biopsy (Phase 1b), with the tissue collection informed consent signed.
- Enough tissue collected at salvage surgery (Phase 1a) or biopsy (Phase 1b) to make at least 3 doses of vaccine: resectable tumor tissue weighing at least 1 gram (approximately 0.5 to 3 cm³) with adequate cellularity (greater than 40% viable tumor cellularity), as assessed by pathology using the corresponding biopsy or surgical specimen.
Key exclusion criteria (22 listed)
- Nasopharyngeal carcinoma, salivary gland tumors, or non-squamous cell histology of the head and neck.
- Other malignancies within the past 5 years, other than those specified in the inclusion criteria. Patients with prior malignancies, including pelvic cancer, are eligible if disease free for more than 5 years. Patients with prior in situ carcinomas are eligible if there was complete removal.
- Not enough tissue collected at surgery (Phase 1a) or biopsy (Phase 1b) for the planned 3 doses (resectable tumor tissue weighing less than 1.0 gram).
- Treatment with chronic immunosuppressants (for example, cyclosporine following transplantation).
- Prior organ allograft or allogeneic bone marrow transplantation.
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 |
|---|---|---|
| TMV VaccineAlso: Tumor Membrane Vesicle Vaccine, MTC-Vaccine-P, MembrexAutologous, personalized tumor membrane vesicle (TMV) vaccine prepared from the participant's own tumor tissue, collected at salvage surgery (Phase 1a) or by biopsy (Phase 1b). Tumor membrane vesicles are modified by protein transfer to display the immunostimulatory molecules IL-12 and B7-1 through glycosylphosphatidylinositol (GPI) anchors. Administered by intradermal injection at dose levels of 0.25 mg, 0.5 mg, or 1.0 mg in Phase 1a, and at the optimal biological dose identified in Phase 1a for Phase 1b. | Biological | Phase 1a Dose Level 1: TMV Vaccine 0.25 mg, Phase 1a Dose Level 2: TMV Vaccine 0.5 mg, Phase 1a Dose Level 3: TMV Vaccine 1.0 mg, Phase 1b: TMV Vaccine + Toripalimab-tpzi |
| Toripalimab-tpziAlso: LOQTORZI, JS001Anti-PD-1 monoclonal antibody administered at 240 mg by intravenous infusion every 3 weeks, for up to 2 doses before salvage surgery and then for up to 1 year after surgery or until disease progression (Phase 1b only). | Biological | Phase 1b: TMV Vaccine + Toripalimab-tpzi |
Primary outcome
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a
Time frame: From first dose through 3 weeks after the last vaccine dose (7 weeks)
A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, except Grade 3 injection site reactions adequately controlled with medical treatment. Reported by dose level.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1a
Time frame: Frame: From first dose through 30 days after the last vaccine dose (approximately 8 weeks)
TEAEs and SAEs graded by severity per NCI CTCAE v6.0, reported by dose level.
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone
Time frame: From first dose through 3 weeks after the last vaccine dose (7 weeks)
RP2D of TMV vaccine monotherapy, selected based on the totality of safety, tolerability, and immunogenicity data across Phase 1a dose levels.
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1b
Time frame: From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months)
A DLT is a TMV vaccine-related adverse event that is Grade 4 hematologic or Grade 3 or higher non-hematologic per NCI CTCAE v6.0, in participants receiving TMV vaccine plus toripalimab-tpzi.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) in Phase 1b
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
TEAEs and SAEs graded by severity per NCI CTCAE v5.0.
Number of Participants With Immune-Related Adverse Events (irAEs) Attributable to Toripalimab-tpzi in Phase 1b
Time frame: From first dose through 30 days after the last dose of study treatment (up to approximately 15 months)
Immune-related adverse events attributed to toripalimab-tpzi, graded by severity per NCI CTCAE v5.0.
Recommended Phase 2 Dose (RP2D) of TMV Vaccine Plus Toripalimab-tpzi
Time frame: From first dose through 3 weeks after the last TMV vaccine dose or last toripalimab-tpzi dose, whichever is later (up to approximately 15 months)
RP2D of TMV vaccine in combination with toripalimab-tpzi, selected based on the totality of safety, tolerability, and immunogenicity data.
9 secondary outcomes
Change From Baseline in T Cell Activation and Phenotype in Peripheral Blood
Time frame: Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6)
Change From Baseline in Plasma Cytokine and Chemokine Levels
Time frame: Before each TMV vaccine dose, and 24 hours and 7 to 9 days after each dose; also 2 weeks after the final dose in Phase 1a (Week 6)
Change in Percentage of Viable Tumor Cells From Baseline Biopsy to Surgical Resection in Phase 1b
Time frame: From pre-treatment biopsy to surgical resection (approximately 10 weeks)
Major Pathologic Response (MPR) Rate in Phase 1b
Time frame: At surgical resection (approximately 10 weeks after biopsy)
Pathologic Complete Response (pCR) Rate in Phase 1b
Time frame: At surgical resection (approximately 10 weeks after biopsy)
Objective Response Rate (ORR) per RECIST v1.1 in Phase 1b
Time frame: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Disease Control Rate (DCR) per RECIST v1.1 in Phase 1b
Time frame: At pre-surgical restaging after neoadjuvant treatment (approximately 6 weeks after first dose)
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Overall Survival (OS)
Time frame: Up to 3 years
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 27 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers. Study results may be published in aggregate in peer-reviewed journals.
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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.
Raja Nicholas, PhD contact
Periasamy Selvaraj, PhD study director
Metaclipse Therapeutics
Michael Coleman, PhD study director
Metaclipse Therapeutics
Christopher Pack, PhD study director
Metaclipse Therapeutics
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 TMV Vaccine and Toripalimab-tpzi in people with Squamous Cell Carcinoma of Head and Neck and Squamous Cell Carcinoma of Head and Neck (SCCHN), run by Metaclipse Therapeutics Corporation 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 28 inclusion and 22 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 27 Oct 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 Anthony Lazaro Manliguez, BS (3462120610, amanliguez@metaclipse.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Dose-Limiting Toxicities (DLTs) in Phase 1a (time frame: From first dose through 3 weeks after the last vaccine dose (7 weeks)). The study lists 7 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 27 Oct 2026.