Clinical trial · Interventional
Immunotherapy of Advanced Cancer Using a Combination Nimotuzumab and NK Cells
A Phase I Trial of Combined Nimotuzumab With NK Cells Adoptive Transfer for the Treatment of Advanced Cancer
- 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)
NK cells can persist and expand in vivo following adoptive transfer and may have a role in the treatment of late stage malignancies. NK also express an activating Fc receptor that mediates antibody-dependent cellular cytotoxicity (ADCC) and production of immune modulatory cytokines in response to antibody-coated targets. Nimotuzumab, an monoclonal antibody against EGFR (epidermal growth factor receptor), may enhance the ADCC effect of NK cell. This study will evaluate the safety of combination of nimotuzumab and NK Cell in treating advanced cancer patients. Blood samples will also be collected for research purposes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adaptive Transfer | — | UNRESOLVED | — |
| ADCC | — | UNRESOLVED | — |
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Nimotuzumab | — | UNRESOLVED | — |
| NK Cell Mediated Immunity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nimotuzumab | Drug | Nimotuzumab | ALIAS |
| NK Cell adaptive transfer | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Peripheral blood lymphocytes will be collected. The NK cell will be selected and expanded ex vivo, then adaptive transfer back into patients. A total of 5.0 x 10\^8/L NK cells will be infused in one cycle.To avoid allergic reactions, 50 mg hydrocortisone was intramuscularly injected into patient 30 min before cells infusion every time. Best supportive care was also provided for patients. Nimotuzumab will be used 24 hours before infusion. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT and PET-CT or they withdrew consent.
- interventionNames
- Biological: NK Cell adaptive transfer
- Drug: Nimotuzumab
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 6 month
- description
- Number of Patients with Clinical or Biological Treatment-related Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of a Combination of Nimotuzumab and NK Cell as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed recurrent or metastatic cancer 2. Measurable disease 3. Progressed after all standard treatment 4. ECOG performance status of 0 to 2 5. Expected life span ≥ 3 months 6. Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy 7. Major organs function normally 8. Women at pregnant ages should be under contraception 9. Willing and able to provide informed consent Exclusion Criteria: 1. Other malignancy within 5 years prior to entry into the study, expect for treated non melanoma skin cancer and cervical carcinoma in situ 2. Poor vasculature 3. Disease to the central nervous system 4. Blood-borne infectious disease, eg. hepatitis B 5. History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician 6. With other immune diseases, or chronic use of immunosuppressants or steroids 7. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception) 8. Breastfeeding 9. Decision of unsuitableness by principal investigator or physician-in-charge
References
Publications (0)
Data not yet available