Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT02869217|
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : September 28, 2018
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 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 pre-treatment and to evaluate evidence of efficacy of TBI-1301 using RECIST v1.1.
|Condition or disease||Intervention/treatment||Phase|
|NY-ESO-1 Expressing Solid Tumors in HLA-A2 Positive Patients Synovial Sarcoma Melanoma Esophageal Cancer Ovarian Cancer Lung Cancer Bladder Cancer Liver Cancer||Drug: Cyclophosphamide Biological: TBI-1301||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Dose Level -1, Dose Level 1, RP2D (expansion)
Cyclophosphamide will be given intravenously (by vein) at a fixed dose of 750mg/m2/d for 2 days
- Safety profile (i.e. adverse events, presence/absence of RCR, analysis of clonality and PK of TBI-1301) assessed by CTCAE v.4.0 and laboratory testings. [ Time Frame: 8 weeks ]
- Recommended phase 2 (RP2D) dose o TBI-1301 when administered following cyclophosphamide pre-treatment [ Time Frame: 8 weeks ]
- Evidence of efficacy (i.e. anti-tumor effect) of TBI-1301 measured using RECIST v1.1 [ Time Frame: 8 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02869217
|Contact: Marcus Butler, MDfirstname.lastname@example.org|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Marcus Butler, M.D. 416-946-4521 email@example.com|
|Principal Investigator: Marcus Butler, M.D.|