Trials / Unknown
UnknownNCT03044743
PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies
A Phase I/II Trial of PD-1 Knockout EBV-CTLs for Advanced Stage EBV Associated Malignancies
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Yang Yang · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be collected for research purposes.
Detailed description
This is a study of CRISPR-Cas9 mediated PD-1 knockout-T cells from autologous origin. Patients are assigned to receive 4 circles of cell therapy. The safety and clinical response are evaluated. Biomarkers and immunological markers are also monitored.
Conditions
- Stage IV Gastric Carcinoma
- Stage IV Nasopharyngeal Carcinoma
- T-Cell Lymphoma Stage IV
- Stage IV Adult Hodgkin Lymphoma
- Stage IV Diffuse Large B-Cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | To modify immune micro-environment |
| DRUG | Cyclophosphamide | To modify immune micro-environment |
| DRUG | Interleukin-2 | To sustain the survival of infused T cells |
Timeline
- Start date
- 2017-04-07
- Primary completion
- 2020-03-01
- Completion
- 2022-03-01
- First posted
- 2017-02-07
- Last updated
- 2017-05-02
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03044743. Inclusion in this directory is not an endorsement.