Clinical trial · Interventional
Vaccination of Metastatic Breast Cancer Patients With a CD80-modified Allogeneic Cancer Cell Line (KS2422)
Phase 1 Study: Induction of Systemic Immune Responses in Metastatic Breast Cancer Patients by Vaccination With a CD80-modified, Devitalized HLA-*A0201+ Breast Cancer Cell Line (KS24.22)
- 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)
In the last few years there has been a great attempt to develop active immunotherapies for breast cancer patients (BCPs) using undefined as well as selected antigens to activate tumor specific T-lymphocytes. The purpose of this phase-I study was to determine the safety and feasibility of vaccinations with an allogeneic breast cancer cell line, KS24.22, genetically modified to express CD80 and Her-2/neu, and to evaluate the efficacy of inducing tumor antigen-specific immune responses in human leukocyte antigen(HLA)-A\*02-matched patients with metastatic breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KS24.22 cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KS24.22-vaccination
- description
- The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD). Immediately before administration, KS24.22 cells were thawed and lethally irradiated. KS24.22 cells were adjusted to 10E7/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites.
- interventionNames
- Biological: KS24.22 cells
Primary outcomes (2)
- measure
- safety of KS24.22 administration
- timeFrame
- 2 years
- measure
- feasibility
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* proven diagnosis of carcinoma of the breast with distant metastatic disease
* patient received either anthracycline- or taxane-based chemotherapy ("state of the art")
* Karnofsky Score (performance status) 80%
* HLA-\*A0201-positive
* minimum life expectancy of 6 month
* written informed consent
* activation of patient's T-lymphocytes by mitogen antibodies and the cell line used for vaccination
Exclusion Criteria:
* manifestation of CNS metastases
* immunosuppressive disease like AIDS, autoimmune disease
* no serious concomitant systemic medical disorders or active acute or systemic infection
* pregnancy
* chemotherapies or radiotherapies in the 4 weeks preceding study entry
* biological response modifiers (antibodies, TNF, cytokines) or other immune therapies in the 6 weeks preceding study entry (exclusion: hematopoetic growth factors)
* organ transplanted patientsReferences
Publications (1)
- RESULTGuckel B, Stumm S, Rentzsch C, Marme A, Mannhardt G, Wallwiener D. A CD80-transfected human breast cancer cell variant induces HER-2/neu-specific T cells in HLA-A*02-matched situations in vitro as well as in vivo. Cancer Immunol Immunother. 2005 Feb;54(2):129-40. doi: 10.1007/s00262-004-0583-z. Epub 2004 Sep 9. PMID 15365776