Recruiting
Phase 1

TMV Vaccine & Toripalimab-tpzi

Sponsor:

Metaclipse Therapeutics Corporation

Code:

NCT07898124

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TMV Vaccine

Toripalimab-tpzi

Study Details

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.

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

Study ID

NCT07898124

Start date

Oct 1, 2026

Status verified date

Oct, 2026

Completion date

Feb 28, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a Dose Level 1: TMV Vaccine 0.25 mg

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.

experimental: Phase 1a Dose Level 2: TMV Vaccine 0.5 mg

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.

experimental: Phase 1a Dose Level 3: TMV Vaccine 1.0 mg

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.

experimental: Phase 1b: TMV Vaccine + Toripalimab-tpzi

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.

Interventions

TMV Vaccine

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-tpzi

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).

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) ]
  • 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) ]
  • Recommended Phase 2 Dose (RP2D) of TMV Vaccine Alone [ Time Frame: From first dose through 3 weeks after the last vaccine dose (7 weeks) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Anthony Lazaro Manliguez, BS

3462120610amanliguez@metaclipse.com

Raja Nicholas, PhD

rnicholas@metaclipse.com

Locations

The University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Israel Glover

832-748-6597IKGlover@MDAnderson.org

Principal Investigator:

Neal Akhave, MD

More Information

Sponsor

Metaclipse Therapeutics Corporation

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Metaclipse Therapeutics Corporation on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.