Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03250325 |
Recruitment Status :
Completed
First Posted : August 15, 2017
Last Update Posted : December 6, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Synovial Sarcoma | Biological: TBI-1301 Drug: Cyclophosphamide | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-center Phase I/II Study of NY-ESO-1 T Cell Receptor Gene Transferred T Lymphocytes in Patients With Synovial Sarcoma |
Actual Study Start Date : | September 20, 2017 |
Actual Primary Completion Date : | January 23, 2020 |
Actual Study Completion Date : | March 9, 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: Split dose of 5x10^9 TBI-1301
Split dose of 5x10^9 TBI-1301 will be administered intravenously for 2 days following cyclophosphamide pre-treatment 750 mg/m2/d for 2 days.
|
Biological: TBI-1301
Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide pre-treatment. Drug: Cyclophosphamide Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301. |
- (Phase I) Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values [ Time Frame: 52 weeks ]Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
- (Phase I) Appearance of replication competent retrovirus (RCR) by PCR [ Time Frame: 52 weeks ]Confirm that no replication competent retrovirus observed.
- (Phase I) Appearance of clonality by linear amplification mediated (LAM)-PCR [ Time Frame: 52 weeks ]Confirm that no clonality is observed.
- (Phase I) Blood kinetics of TBI-1301 by realtime-PCR [ Time Frame: 52 weeks ]Evaluate persistence and expansion of transferred TBI-1301.
- (Phase II) Overall response rate [ Time Frame: 52 weeks ]Evaluate response rate by measuring response using RECIST v1.1 and irRECIST
- (Phase I) Objective response rate [ Time Frame: 52 weeks ]Evaluate response rate by measuring response using RECIST v1.1 and irRECIST
- (Phase I/II) Progression free rate [ Time Frame: 12 weeks ]Evaluate progression free rate by measuring response using RECIST v1.1 and irRECIST
- (Phase I/II) Progression free survival [ Time Frame: 52 weeks ]Evaluate progression free survival
- (Phase I/II) Overall survival [ Time Frame: 52 weeks ]Evaluate overall survival
- (Phase II) Adverse event, mortality, severe adverse event, discontinuation due to adverse event, laboratory test values [ Time Frame: 52 weeks ]Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
- (Phase II) Appearance of RCR [ Time Frame: 52 weeks ]Confirm that no replication competent retrovirus observed.
- (Phase II) Appearance of clonality (LAM-PCR) [ Time Frame: 52 weeks ]Confirm that no clonality is observed.
- (Phase II) Blood kinetics of TBI-1301 by realtime-PCR [ Time Frame: 52 weeks ]Evaluate persistence and expansion of transferred TBI-1301.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed synovial sarcoma
- Surgically unresectable tumor
- Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline
- HLA-A*02:01 or HLA-A*02:06 positive
- Tumor that express NY-ESO-1 by immunohistochemistry
- ≥ 18 years of age
- Measurable lesions that are evaluable by the RECIST ver1.1
- ECOG Performance Status of 0, 1 or 2
- No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
- 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; Total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST(GOT), ALT(GPT) < 3.0 x ULN; Creatinine < 1.5 x ULN; 2,500/μL < WBC ≤ULN; Hemoglobin ≥ 8.0g/dL; Platelets ≥ 75,000/μL
- Patients must be able to understand the study contents and to give a written consent at his/her free will. Additionally, if patients are below 20 years of age, proxies must be able to give a written consent.
Exclusion Criteria:
- Patients with the following conditions 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.
- Active metastatic 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%
- History of serious hypersensitivity reactions to bovine or murine derived substances.
- History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study
- History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.
- Pregnant females, lactating females (except when they cease and do not resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to 6 months after infusion of the investigational drug.
- Clinically significant systemic illness that in the judgment of the PI or sub-investigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.
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): NCT03250325
Japan | |
Sapporo Medical University Hospital | |
Sapporo, Hokkaido, Japan, 060-8543 | |
Mie University Hospital | |
Tsu, Mie, Japan, 514-8507 | |
National Cancer Center Hospital | |
Chuo-ku, Tokyo, Japan, 104-0045 | |
Kyushu University Hospital | |
Fukuoka, Japan, 812-8582 | |
National Hospital Organization Osaka National Hospital | |
Osaka, Japan, 540-0006 |
Study Director: | Masanobu Kimura | Takara Bio Inc. |
Responsible Party: | Takara Bio Inc. |
ClinicalTrials.gov Identifier: | NCT03250325 |
Other Study ID Numbers: |
1301-03 |
First Posted: | August 15, 2017 Key Record Dates |
Last Update Posted: | December 6, 2023 |
Last Verified: | December 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Adoptive cell transfer Cell therapy Immunotherapy |
NY-ESO-1 T cell receptor gene therapy Synovial sarcoma |
Sarcoma Sarcoma, Synovial Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Cyclophosphamide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |