Clinical trial · Interventional
Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
NCT05235607CI-TRIAL-00056492unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor antigen-sensitized vaccine and their sensitized T cells
- description
- Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times. Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times.
- interventionNames
- Biological: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
- timeFrame
- 3 months after the last administration of cells
- description
- Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age:18-75 years * Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions; * Failed in the previous standard therapy; * ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points; * The estimated survival period is ≥3 months; * Rehabilitate from previous therapy; * Adequate organ functions; * Patient's written informed consent; Exclusion Criteria: * Tumor emergencies; * Abnormal coagulation function; * Contagious diseases, such as HIV, HBV, HCV infection; * Mental disorders; * Concomitant tumors; * Immunological co-morbidities
References
Publications (0)
Data not yet available
No reference posted for this study.