Clinical trial · Interventional
T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
NCT02662348CI-TRIAL-00020647unknownPhase 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 phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.
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 |
|---|---|---|---|
| Bowel Cancer | Malignant Intestinal Neoplasm | ALIAS | 0.90 |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HER2Bi-Armed T Cells | Drug | — | UNRESOLVED |
| Recombinant Human Interleukin-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interleukin-2 Transfusion
- description
- Patients receive low-dose Recombinant Human Interleukin-2 SC daily beginning 3 days before the first HER2Bi armed T cell infusions infusion.
- interventionNames
- Drug: Recombinant Human Interleukin-2
- type
- EXPERIMENTAL
- label
- T Cells Transfusion
- description
- Patients receive HER2Bi-Armed T Cells IV weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: HER2Bi-Armed T Cells
Primary outcomes (1)
- measure
- Safety as measured by local and systemic toxicities
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with Her2-positive neoplasms of digestive system: IHC 3+ 2. Clinical staging: Phase III or above 3. Ages: \< 65 4. Expected survival time: \> 1 year 5. Quality of Life: \> 60 6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal 7. The volunteers with informed consent Exclusion criteria: 1. Patient with Her2-negative neoplasms of digestive system 2. Hepatic renal dysfunction 3. Cardiopulmonary insufficiency 4. Mental disorder 5. Allergic condition 6. With other malignant tumor 7. Lactating women 8. Patients with infection or received chemotherapy in the past two weeks 9. Patient with autoimmune disease using immunosuppressive drug 10. Patient with organ transplantation with long term use of immunosupresive drug
References
Publications (26)
- BACKGROUNDMolina MA, Codony-Servat J, Albanell J, Rojo F, Arribas J, Baselga J. Trastuzumab (herceptin), a humanized anti-Her2 receptor monoclonal antibody, inhibits basal and activated Her2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001 Jun 15;61(12):4744-9. PMID 11406546
- BACKGROUNDRoss JS, Slodkowska EA, Symmans WF, Pusztai L, Ravdin PM, Hortobagyi GN. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009 Apr;14(4):320-68. doi: 10.1634/theoncologist.2008-0230. Epub 2009 Apr 3. PMID 19346299
- BACKGROUNDJorgensen JT. Targeted HER2 treatment in advanced gastric cancer. Oncology. 2010;78(1):26-33. doi: 10.1159/000288295. Epub 2010 Feb 25. PMID 20185938
- BACKGROUNDCamilleri-Broet S, Hardy-Bessard AC, Le Tourneau A, Paraiso D, Levrel O, Leduc B, Bain S, Orfeuvre H, Audouin J, Pujade-Lauraine E; GINECO group. HER-2 overexpression is an independent marker of poor prognosis of advanced primary ovarian carcinoma: a multicenter study of the GINECO group. Ann Oncol. 2004 Jan;15(1):104-12. doi: 10.1093/annonc/mdh021. PMID 14679128
- BACKGROUNDJanjigian YY, Werner D, Pauligk C, Steinmetz K, Kelsen DP, Jager E, Altmannsberger HM, Robinson E, Tafe LJ, Tang LH, Shah MA, Al-Batran SE. Prognosis of metastatic gastric and gastroesophageal junction cancer by HER2 status: a European and USA International collaborative analysis. Ann Oncol. 2012 Oct;23(10):2656-2662. doi: 10.1093/annonc/mds104. Epub 2012 Jun 11. PMID 22689179
- BACKGROUNDTakenaka M, Hanagiri T, Shinohara S, Kuwata T, Chikaishi Y, Oka S, Shigematsu Y, Nagata Y, Shimokawa H, Nakagawa M, Uramoto H, So T, Tanaka F. The prognostic significance of HER2 overexpression in non-small cell lung cancer. Anticancer Res. 2011 Dec;31(12):4631-6. PMID 22199341
- BACKGROUNDMimura K, Kono K, Hanawa M, Kanzaki M, Nakao A, Ooi A, Fujii H. Trastuzumab-mediated antibody-dependent cellular cytotoxicity against esophageal squamous cell carcinoma. Clin Cancer Res. 2005 Jul 1;11(13):4898-904. doi: 10.1158/1078-0432.CCR-04-2476.