Clinical trial · Interventional
An Immunogenic Personal Neoantigen Vaccine for Cancer Treatment
PhaseI Trial of Tumor Neoantigen Vaccine
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite years of preclinical efforts and hundreds of clinical studies, therapeutic cancer vaccines with the routine ability to limit or eliminate tumor growth in humans have been elusive. With advances in genome sequencing, it is now possible to identify a new class of tumor-specific antigens derived from mutated proteins that are present only in the tumor. These "neoantigens" should provide highly specific targets for antitumor immunity. Although many challenges remain in producing and testing neoantigen-based vaccines customized for each patient, a neoantigen vaccine offers a promising new approach to induce highly focused antitumor T cells aimed at eradicating cancer cells
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| tumor neoantigen | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- vaccinated group
- description
- Neoantigen vaccination will be performed with 6 doses in total, once per week
- interventionNames
- Biological: tumor neoantigen
Primary outcomes (1)
- measure
- Safety of the immunogenic personal neoantigen vaccine
- timeFrame
- 1.5 years
- description
- The incidence of serious adverse events
Secondary outcomes (1)
- measure
- Disease control rate
- timeFrame
- 1 year
- description
- It is defined as the proportion of complete response, partial response and stable disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years ≤ 70 years at the time of informed consent * Signed informed consent to be provided * failed in previous standard chemotherapy and targeted therapy * Life expectancy not less than 90 days * Karnofsky performance status 0-1 * adequate organ functions Exclusion Criteria: * Actively infectious condition including hepatitis * Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. * Any form of primary immunodeficiency (such as Severe Combined immunodeficiency Disease). * Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). * Active systemic infections, coagulation disorders or any other active major medical illnesses. * Patients who are receiving any other investigational agents.
References
Publications (0)
Data not yet available