Clinical trial · Observational
Development of Immunological Assays for the Evaluation of Tumor Antigen Specific Immunity
Phase 0 Study for the Development of Immunological Assays for the Evaluation of WT-1, Survivin and HPV16 E7 Tumor Antigens Specific Immune Responses in Cancer Patients
- 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 study is a clinical study aiming at establishing immunological assays for the qualitative and quantitative evaluation of WT-1, Survivin and HPV16 E7-specific immune responses in cancer patients. Such a study will allow the development of suitable immunological tools to be used in assessing response in a subsequent phase I study aiming at evaluating therapeutic vaccine candidates targeting WT-1, Survivin and/or HPV16 E7-expressing tumors. In addition, this study will help defining the baseline cancer-associated immune responses in the selected patient population. Cervical and ovarian cancer patients, as well as leukemia patients, will be included in this study. WT-1, Survivin and HPV-specific immune responses will be monitored in these patients by ex vivo and cultured IFNg ELISpot as well as tetramer staining.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Intraepithelial Neoplasia, Grade 3 | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.85 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Ovarian Serous Adenocarcinoma | Ovarian Serous Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Undifferentiated Carcinoma of Ovary | Ovarian Undifferentiated Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cancer patients
- description
- Patient with histologically confirmed diagnosis of cervical cancer or cervical intraepithelial neoplasia (grade 3) or of high-grade serous (or undifferentiated) ovarian cancer or patients with AML or CML confirmed by bone marrow biopsy or peripheral blood Not treated - prior standard of care therapy acceptable one blood sampling performed on the visit day
- interventionNames
- Procedure: Blood Sampling
Primary outcomes (1)
- measure
- Development and validation of ELISpot and tetramer assays for the detection of tumor-antigen specific T cell immune responses in cancer patients
- timeFrame
- Baseline
- description
- Direct and cultured IFNg ELISpot as well as direct tetramer staining assays will be set up and qualified for the detection WT-1, survivin and HPV16 E7 specific immune responses in cancer patients
Secondary outcomes (1)
- measure
- Characterisation of WT1, Survivin and HPV16 E7 specific immune responses in cancer patients
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Specific Inclusion criteria * For ovarian cancer patients: Histologically confirmed surgical diagnosis of high-grade serous (or undifferentiated) ovarian cancer * For CIN3 and cervical cancer patients: Histologically confirmed diagnosis of CIN3 or cervical cancer * For AML and CML patients: HLA-A2 positivity and diagnosis of AML or CML confirmed by bone marrow biopsy or peripheral blood * Shared inclusion criteria * No evidence of active progressive disease. For ovarian cancer patients, a woman with a rising CA125 and negative imaging is acceptable * Age ≥ 18 yrs and \< 70 yrs * ECOG 0-2 * Adequate hematologic assessment (results from the previous standard of care visit): * Absolute neutrophil count (ANC) greater than or equal to 1.0 x 109/L * Platelets greater than or equal to 100 x 109/L. * Written informed consent Exclusion Criteria: * Treatment with chemotherapy, radiation therapy, other immunotherapy or non-topical steroids within the past 3 weeks prior to initiation of the study. * Immunosuppressive therapy (excluding topical steroids) for any other condition. * Recurrent/progressive disease confirmed clinically, radiologically or histologically before entry into the study. (exclude versus inclusion criteria) * Persistent fever (\>24 hours) documented by repeated measurement or active uncontrolled infection in the last 4 weeks. * Active autoimmune disease, including, but not limited to, SLE, MS, ankylosing spondylitis.
References
Publications (0)
Data not yet available