Trials / Active Not Recruiting
Active Not RecruitingNCT02869217
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
Summary
The target populations for this phase I study with TBI-1301 are patients with advanced solid tumors. Patients' tumors will be required to express NY-ESO-1, which include but is not limited to ovarian cancer, synovial sarcoma, esophageal cancer, lung cancer, bladder cancer, liver cancer, and malignant melanoma. Patients must be positive for HLA-A\*02:01 or HLA-A\*02:06 and the patient's tumor tissue must be positive for NY-ESO-1 antigen expression. The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with advanced solid tumors. The purpose of this study is to evaluate the safety profile of TBI-1301, to determine the recommended phase 2 (RP2D) dose of TBI-1301 when administered following cyclophosphamide and fludarabine pre-treatment, to evaluate the safety of repeat dosing of TBI-1301, to assess the presence/absence of RCR appearance after TBI-1301 infusion, to assess the presence or absence of clonality by LAM-PCR, and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.
Conditions
- NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients
- Synovial Sarcoma
- Melanoma
- Esophageal Cancer
- Ovarian Cancer
- Lung Cancer
- Bladder Cancer
- Liver Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclophosphamide | |
| BIOLOGICAL | TBI-1301 | |
| DRUG | Fludarabine |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2016-08-16
- Last updated
- 2025-12-03
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02869217. Inclusion in this directory is not an endorsement.