Clinical trial · Interventional
Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer
Phase Ia/Ib Trial of 2nd Generation Anti-CEA Designer T Cells in Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding
Summary
Brief summary (as posted)
The purpose of this study is to collect data on the safety and effectiveness of 2nd generation designer T cells in patients with breast cancer. Designer T cells are prepared by collecting white blood cells from the participant, and then modifying these cells in the laboratory so that they recognize the tumor antigen (CEA). These modified cells are then given back to the participant so that they can attack and kill tumor 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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gene Modified T Cells | Biological | — | UNRESOLVED |
| Gene Modified T Cells and Interleukin 2 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase Ia
- interventionNames
- Biological: Gene Modified T Cells
- type
- EXPERIMENTAL
- label
- Phase Ib: Control
- interventionNames
- Biological: Gene Modified T Cells and Interleukin 2
Primary outcomes (2)
- measure
- Phase Ia:Determine the safety of using modified T-cells by documenting the type and severity of any side effects and establishing the maximum tolerated dose (MTD).
- timeFrame
- 1 Month
- measure
- Phase Ib: Determine optimal biologic dose (OBD) in terms of value of added interleukin 2.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have cancer of the breast * Must have metastatic or unresectable locally advanced disease * Tumor must express CEA by tumor staining or by elevated serum CEA (\>10 ng/ml) * Must have measurable disease radiologically or by physical exam * Must have failed potentially curative standard therapy * Must be 18 years of age or older * Good performance status (PS 0-1) Exclusion Criteria: * Requiring systemic steroids * Serious medical conditions * Concurrent malignancies
References
Publications (0)
Data not yet available