NCT07898124|RecruitingPhase 1DMCFDA Drug

TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma

Phase 1 Study of TMV Vaccine Alone or TMV Vaccine Plus Toripalimab-tpzi in Loco-Regionally Recurrent Head and Neck Squamous Cell Carcinoma

Metaclipse Therapeutics Corporation ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

MTC-004

Study Type

interventional

Estimated enrollment

Locations

1 country

Sites

Timeline

Study Start

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

December 31, 2030

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

February 28, 2031

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Brief 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 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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 30 participants
Study completion date: February 28, 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 1, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
First Submitted
October 4, 2026
Actual (reported)
First Posted
October 27, 2026
Actual (reported)
Primary Completion
December 31, 2030
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 28, 2031
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: October 27, 2026
Status Verified: October 2026
Last Update Submitted: October 20, 2026

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

Outcome Measures

Primary Outcomes (7)

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.
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.
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.
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.
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.
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.
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.
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
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
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
From pre-treatment biopsy to surgical resection (approximately 10 weeks)
Major Pathologic Response (MPR) Rate in Phase 1b
At surgical resection (approximately 10 weeks after biopsy)
Pathologic Complete Response (pCR) Rate in Phase 1b
At surgical resection (approximately 10 weeks after biopsy)
+4 more secondary outcomes

Other Outcomes (5)

Correlation Between Tumor PD-L1 Combined Positive Score (CPS) and Immune Stimulating Activity
From baseline through end of treatment (up to approximately 15 months)
Correlation Between Baseline CD8+ Tumor-Infiltrating Lymphocyte (TIL) Density and Immune Stimulating Activity
From baseline through end of treatment (up to approximately 15 months)
Correlation of Tumor Cellularity With TMV Vaccine Yield
At tumor tissue collection and vaccine production (baseline)
+2 more other outcomes

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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
+13 more criteria

You may not qualify if:

Nasopharyngeal carcinoma, salivary gland tumors, or non-squamous cell histology of the head and neck.
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.

Contact the study team to confirm eligibility.

TMV Vaccine Alone or With Toripalimab-tpzi for Recurrent Head and Neck Squamous Cell Carcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (9)

Other Outcomes (5)

Study Arms (4)

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

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (7)

Secondary Outcomes (9)

Other Outcomes (5)

Study Arms (4)

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

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Source record

Locations