Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngea… (NCT05582590) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Autologous T Cells Targeting HPV16 HPV18 & Survivin in Patients With R/R HPV-related Oropharyngeal Cancers
36 participantsStarted 2025-03-31
Plain-language summary
This is a multicenter, open-label, Phase I, first-in-human trial to characterize the safety and clinical activity of an antigen-specific CD8+ T-cell product in patients with relapsed or refractory locally advanced or metastatic HPV-related oropharyngeal cancers. Patients must have received at least one prior standard treatment regimen consisting of systemic immunotherapy and/or chemotherapy. The investigative agent is an autologous adoptive T-cell product derived from the patient's endogenous cytolytic T cells that are directed toward HPV-16 E6/E7, HPV-18 E6/E7 antigens, and a tumor-associated antigen (Survivin) by ex vivo exposure to an artificial antigen presenting cell to which HLA-A2 antigen-peptides have been fit within the pocket of an MHC class 1 molecule. Patients must express HLA-A\*0201.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. The patient will be typed for HLA-A\*0201 expression as determined by high resolution sequence-based typing method. If documented HLA results are available from a previous test, the patient can be enrolled using these results after review and approval by the sponsor.
✓. Patients with cytologically or histologically confirmed locally advanced or metastatic HPV related oropharyngeal cancers with confirmed detection of HPV-16 and/or HPV-18.
✓. Patients with HPV-related oropharyngeal cancers who have received at least 1 prior line of standard-of-care (SOC) treatment (for example, per the current NCCN Guidelines for Patients with Oropharyngeal Cancer) consisting of systemic immunotherapy and/or chemotherapeutic treatment.
✓. The last dose of cytotoxic chemotherapy and/or steroids must be administered at least 28 days prior to the leukapheresis procedure.
✓. Any adverse event(s) that the patient may have experienced from prior therapy must have resolved to ≤ Grade 1 according to NCI CTCAE version 5.0.
✓. Measurable disease per RECIST v1.1 criteria (at least 1 lesion that can be measured accurately in at least 1 dimension with the longest diameter ≥ 10 mm \[MRI or CT scan sliced thickness ≤ 5 mm\]).
✓. Pulse oximetry ≥ 92% on room air.
✓
What they're measuring
1
Adverse Events (AEs)
Timeframe: 12 months
2
Dose-Limiting Toxicities (DLTs)
Timeframe: 28 days
3
Severities of AEs
Timeframe: 12 months
4
Relationship of AEs
Timeframe: 12 months
5
Serious Adverse Events (SAEs)
Timeframe: 12 months
6
Adverse Events of Special Interest (AESIs) - Cytokine Release Syndrome (CRS)
Timeframe: 12 months
7
Adverse Events of Special Interest (AESIs) - Immune Effector cell-associated neurotoxicity syndrome (ICANS)
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
✕. A diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. Exceptions are non-metastatic basal cell or squamous cell carcinomas of the skin or prostate cancer that does not require treatment. Patients taking adjuvant hormonal therapy for definitively treated cancers (e.g., breast cancer, prostate cancer) are eligible.
✕. Major surgery within 28 days prior to the first study drug administration (minimally invasive procedures, such as diagnostic biopsies, are permitted).
✕. Known central nervous system involvement.
✕. Treatment with an allogeneic hematopoietic stem cell transplantation.
✕. Treatment with any investigational agent(s) at the time of informed consent.
✕. Left ventricular ejection fraction (LVEF) \< 45%, congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
✕. The following hematological laboratory results at Screening (these results must be independent of blood product or hematopoietic growth factor support):