Investigator Initiated Phase 1 Study of TBI-1301
Multi-center, Investigator Initiated Phase 1 Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors
1 other identifier
interventional
9
1 country
1
Brief Summary
Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2015
CompletedFirst Posted
Study publicly available on registry
February 19, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedOctober 24, 2018
October 1, 2018
3.5 years
February 12, 2015
October 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Incidence and grade of adverse events (CTCAE)
• Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
4 weeks
Appearance of replication competent retrovirus by PCR
Confirm no replication competent retrovirus observed.
4 weeks
Appearance of clonality by LAM-PCR
Confirm no clonality is observed.
4 weeks
Kinetics of TBI-1301 in blood by realtime-PCR
Evaluate persistence and expansion of transferred TBI-1301.
8 weeks
Study Arms (4)
Low dose TBI-1301 with pre-treatment 1
EXPERIMENTALTBI-1301(5\*10\^8) single-dose administration with pre-treatment of cyclophosphamide alone.
High dose TBI-1301 with pre-treatment 1
EXPERIMENTALTBI-1301(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide alone.
High dose TBI-1301 with pre-treatment 2
EXPERIMENTALTBI-1301(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide and fludarabine.
TBI-1301 with pre-treatment 1 or 2
EXPERIMENTALArm1, 2 or 3, which is considered as optimal.
Interventions
TBI-1301(5\*10\^8 or 5\*10\^9) is administered.
Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1301 in combination with cyclophosphamide.
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed solid tumors
- Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc)
- HLA-A\*02:01 or HLA-A\*02:06 positive
- NY-ESO-1-expression by PCR or immunohistochemistry
- ECOG Performance Status, 0 or 1
- Age \>=20 years on consent
- No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
- Life expectancy \>=16 weeks after consent
- No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:
- WBC \>= 2,500/μL
- Hemoglobin \>= 8.0g/dL
- Platelets \>= 75,000/μL
- T. bilirubin \< 1.5 x ULN
- AST(GOT), ALT(GPT) \< 3.0 x ULN
- Creatinine \< 1.5 x ULN
- +1 more criteria
You may not qualify if:
- The following serious complications are excluded from the study;
- Unstable angina, cardiac infarction, or heart failure
- Uncontrolled diabetes or hypertension
- Active infection
- Obvious interstitial pneumonia or lung fibrosis by chest X-ray
- Active autoimmune disease requiring steroids or immunosuppressive therapy.
- Serious hypersensitivity
- Tumor cell invasion into CNS
- Active multiple cancer
- Positive for HBs antigen or HBV-DNA observed in serum
- Positive for HCV antibody and HCV-RNA observed in serum
- Positive for antibodies against HIV or HTLV-1
- Left Ventricular Ejection Fraction (LVEF): \<= 50％
- Percutaneous Oxygen saturation: \< 94％
- History of serious hypersensitivity reactions to bovine or murine derived substances.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mie Universitylead
- Takara Bio Inc.collaborator
- Shionogicollaborator
- Fiverings Co., Ltd.collaborator
- Statcom Co. Ltd.collaborator
Study Sites (1)
Mie University Hospital
Tsu, Mie-ken, Japan
Related Publications (1)
Ishihara M, Kitano S, Kageyama S, Miyahara Y, Yamamoto N, Kato H, Mishima H, Hattori H, Funakoshi T, Kojima T, Sasada T, Sato E, Okamoto S, Tomura D, Nukaya I, Chono H, Mineno J, Kairi MF, Diem Hoang Nguyen P, Simoni Y, Nardin A, Newell E, Fehlings M, Ikeda H, Watanabe T, Shiku H. NY-ESO-1-specific redirected T cells with endogenous TCR knockdown mediate tumor response and cytokine release syndrome. J Immunother Cancer. 2022 Jun;10(6):e003811. doi: 10.1136/jitc-2021-003811.
PMID: 35768164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hiroshi Shiku, M.D., Ph.D.
Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital
- PRINCIPAL INVESTIGATOR
Shinichi Kageyama, M.D., Ph.D.
Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2015
First Posted
February 19, 2015
Study Start
March 1, 2015
Primary Completion
September 1, 2018
Last Updated
October 24, 2018
Record last verified: 2018-10