Personalized vaccine targeting neoantigens for advanced solid tumors

A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

This study is testing a personalized vaccine made from patients' own cells to see if it can help people with advanced solid tumors, like head and neck cancer or non-small cell lung cancer, by targeting specific cancer markers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06682117 on ClinicalTrials.gov

What this trial studies

This clinical study investigates a personalized self-dendritic cell (DC) vaccine that targets neoantigens in patients with advanced solid tumors, particularly focusing on head and neck cancer and non-small cell lung cancer without driver mutations. The study aims to enroll approximately 9 patients to assess the dose-limiting toxicity and determine the recommended dose for future studies. Utilizing a 3 plus 3 design, the trial will evaluate two different dose levels of the Neo-DC vaccine to establish safety and efficacy parameters.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-75 with confirmed advanced solid tumors that are neoantigen positive and have failed standard treatments.

Not a fit: Patients with solid tumors that do not express neoantigens or those who have not failed standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and personalized treatment option for patients with advanced solid tumors.

How similar studies have performed: While personalized cancer vaccines are an emerging field, this specific approach targeting neoantigens is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. 18-75 years.
2. Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).
3. HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).
4. Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).
5. Before enrollment, systemic standard treatment failure or standard treatment intolerance, and meet the following tumor requirements : new antigen positive（head and neck tumors, non-small cell lung cancer without driver genes (no EGFR sensitive mutation / ALK fusion positive), esophageal squamous cell carcinoma).
6. Voluntary to participate in clinical research ; the person or legal guardian fully understands and is informed of this study and sign the informed consent; willing to follow and be able to complete all test procedures;
7. ECOG score 0-1.
8. Have a venous access to meet single collection or venous blood collection;
9. Expected survival time ≥ 6 months.
10. Subjects were willing to study the use of reliable contraceptive methods during treatment and within 3 months after the end of treatment, and women of childbearing age.
11. Have adequent organ functions.
12. Before administration of Neo-DCV injection : 1) any chemotherapy, targeted drugs, immune checkpoint inhibitors, other clinical trial research drugs, traditional Chinese medicine with anti-tumor indications and other anti-tumor treatments received have passed the 4-week elution period, and the toxic and side effects returned to grade 1 or lower (except for alopecia, vitiligo and other tolerable events judged by researchers) ; 2) If undergoing major surgery within 3 weeks, the adverse reactions have returned to grade 1 or lower.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Patients with a history of severe immediate allergies to the cells and any drugs used in this study.
3. Those with a history of organ transplantation.
4. Known central nervous system metastasis.
5. Any active autoimmune disease or any autoimmune disease that has been determined by the researchers to be unsuitable for this study.
6. Uncontrolled concomitant diseases or infectious diseases, such as the need for systemic antibiotics within 2 weeks before enrollment.
7. Suffering from severe liver and kidney function damage (liver, kidney treatment but still not controllable, biochemical indicators can not meet the inclusion criteria of NO.11, or can not control the diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or poor drug control of hypertension ( systolic blood pressure more than 160mmHg and/or diastolic blood pressure more than 90mmHg), or with clinical Bed meaning (e.g. activity ) of cardiovascular and cerebrovascular diseases, such as cerebrovascular accident (6 months before signing informed consent) unstable angina, myocardial infarction (within 6 months before signing informed consent), unstable angina, New York Heart Association, or any circumstances which, in the opinion of the researcher, may increase the risk of the subject or interfere with the results of the test.
8. Subjects planned to receive sugar within 4 weeks before the first Neo-DCV injection and during the study period due to certain conditions.

   Corticosteroids (prednisone or the same drug dose less than 10mg/day ) or other immunosuppressive agents were excluded.
9. Subjects were scheduled to receive Neo-DCV injection within 4 weeks before the first administration and during the study period due to certain conditions.
10. The researchers assessed that the subjects were unable or unwilling to comply with the requirements of the study protocol.
11. The defects of antigen presentation, antigen recognition and cell killing related genes were detected by sequencing.
12. There was a history of other malignant tumors in the past 5 years, except for curable basal cell carcinoma, papillary thyroid carcinoma, and uterus.
13. Subjects have any disease or medical condition that may affect the evaluation of the safety or efficacy of the study drug.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xianghua Wu, M.D — Fudan University
• Study coordinator: Dongmei Ji, M.D

Conditions Treatment; Neoantigen; Vaccine; Solid Tumor Cancer; advanced solid tumors; DC vaccine; neoantigen