Investigator Initiated Phase 1 Study of TBI-1201
Multi-center, Investigator Initiated Phase 1 Study of MAGE-A4 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors
1 other identifier
interventional
18
1 country
1
Brief Summary
Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2014
Longer than P75 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
March 19, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedJune 18, 2021
June 1, 2021
6.9 years
March 19, 2014
June 13, 2021
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.
8 weeks
Appearance of replication competent retrovirus by PCR
Confirm no replication competent retrovirus observed
8 weeks
Appearance of clonality by LAM-PCR
Confirm no clonality is observed
8 weeks
Kinetics of TBI-1201 in blood by realtime-PCR and flow cytometry
Evaluate persistence and expansion of transferred TBI-1201
8 weeks
Study Arms (4)
Low dose TBI-1201 with pre-treatment 1
EXPERIMENTALTBI-1201(5\*10\^8) single-dose administration with pre-treatment of cyclophosphamide alone.
High dose TBI-1201 with pre-treatment 1
EXPERIMENTALTBI-1201(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide alone.
High dose TBI-1201 with pre-treatment 2
EXPERIMENTALTBI-1201(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide and fludarabine.
TBI-1201 with pre-treatment 1 or 2
EXPERIMENTALArm1, 2 or 3, which is considered as optimal.
Interventions
TBI-1201(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-1201
Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1201 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) , metastatic or recurrent
- HLA-A\*24:02 positive
- MAGE-A4-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/antibody, HBc antibody, or HCV antibody, and virus DNA observed in serum, except for HBs antibody positive case who had vaccine injection before.
- Positive for antibodies against HIV or HTLV-1
- Left Ventricular Ejection Fraction (LVEF): =\< 50％
- Percutaneous Oxygen saturation: \< 94％
- History of hypersensitivity reactions to bovine or murine derived substances.
- History of hypersensitivity reaction to drugs used in this study
- +3 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
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
- PRINCIPAL INVESTIGATOR
Shinichi Kageyama, M.D., Ph.D.
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
March 19, 2014
First Posted
March 26, 2014
Study Start
April 1, 2014
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
June 18, 2021
Record last verified: 2021-06