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Study of TBI-1301 (NY-ESO-1 T Cell Receptor Gene Transduced Autologous T Lymphocytes) in Patients With Synovial Sarcoma

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ClinicalTrials.gov Identifier: NCT03250325
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Takara Bio Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide pre-treatment.

Condition or disease Intervention/treatment Phase
Synovial Sarcoma Biological: TBI-1301 Drug: Cyclophosphamide Phase 1 Phase 2

Detailed Description:
Following pre-treatment with cyclophosphamide, NY-ESO-1-specific T cell receptor (TCR) gene transduced T lymphocytes are transferred to human leukocyte antigen (HLA)-A*02:01 or HLA-A*02:06 positive patients with synovial sarcoma expressing NY-ESO-1, which are surgically unresectable and refractory to anthracycline therapy. The primary objective is to evaluate the safety in the phase 1 and the efficacy in the phase 2.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : July 2020


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.




Primary Outcome Measures :
  1. (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.

  2. (Phase I) Appearance of replication competent retrovirus (RCR) by PCR [ Time Frame: 52 weeks ]
    Confirm that no replication competent retrovirus observed.

  3. (Phase I) Appearance of clonality by linear amplification mediated (LAM)-PCR [ Time Frame: 52 weeks ]
    Confirm that no clonality is observed.

  4. (Phase I) Blood kinetics of TBI-1301 by realtime-PCR [ Time Frame: 52 weeks ]
    Evaluate persistence and expansion of transferred TBI-1301.

  5. (Phase II) Overall response rate [ Time Frame: 52 weeks ]
    Evaluate response rate by measuring response using RECIST v1.1 and irRECIST


Secondary Outcome Measures :
  1. (Phase I) Objective response rate [ Time Frame: 52 weeks ]
    Evaluate response rate by measuring response using RECIST v1.1 and irRECIST

  2. (Phase I/II) Progression free rate [ Time Frame: 12 weeks ]
    Evaluate progression free rate by measuring response using RECIST v1.1 and irRECIST

  3. (Phase I/II) Progression free survival [ Time Frame: 52 weeks ]
    Evaluate progression free survival

  4. (Phase I/II) Overall survival [ Time Frame: 52 weeks ]
    Evaluate overall survival

  5. (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.

  6. (Phase II) Appearance of RCR [ Time Frame: 52 weeks ]
    Confirm that no replication competent retrovirus observed.

  7. (Phase II) Appearance of clonality (LAM-PCR) [ Time Frame: 52 weeks ]
    Confirm that no clonality is observed.

  8. (Phase II) Blood kinetics of TBI-1301 by realtime-PCR [ Time Frame: 52 weeks ]
    Evaluate persistence and expansion of transferred TBI-1301.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed synovial sarcoma
  2. Surgically unresectable tumor
  3. Progressing or recurrent synovial sarcoma which has been treated with 1-4 regimens of systemic chemotherapies including anthracycline
  4. HLA-A*02:01 or HLA-A*02:06 positive
  5. Tumor that express NY-ESO-1 by immunohistochemistry
  6. ≥ 18 years of age
  7. Measurable lesions that are evaluable by the RECIST ver1.1
  8. ECOG Performance Status of 0, 1 or 2
  9. No treatment such as chemotherapy and be expected to recover fully from the previous treatment at the time of the lymphocytes collection for manufacturing
  10. Life expectancy ≥ 16 weeks after consent
  11. 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
  12. 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:

  1. 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.
  2. Active metastatic tumor cell invasion into CNS
  3. Active multiple cancer
  4. Positive for HBs antigen or HBV-DNA observed in serum
  5. Positive for HCV antibody and HCV-RNA observed in serum
  6. Positive for antibodies against HIV or HTLV-1
  7. Left Ventricular Ejection Fraction (LVEF) ≤ 50%
  8. History of serious hypersensitivity reactions to bovine or murine derived substances.
  9. History of hypersensitivity reaction to ingredients or excipients of investigational drugs used in this study
  10. History of hypersensitivity reaction to antibiotics used in manufacturing for the investigational drug used in this study.
  11. 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.
  12. 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.

Information from the National Library of Medicine

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


Contacts
Contact: Takara Bio Inc. +81-77-565-6970 takara-clinical@takara-bio.co.jp

Locations
Japan
Sapporo Medical University Hospital Recruiting
Sapporo, Hokkaido, Japan, 060-8543
Mie University Hospital Recruiting
Tsu, Mie, Japan, 514-8507
National Cancer Center Hospital Recruiting
Chuo-ku, Tokyo, Japan, 104-0045
Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
National Hospital Organization Osaka National Hospital Recruiting
Osaka, Japan, 540-0006
Sponsors and Collaborators
Takara Bio Inc.
Investigators
Study Director: Masanobu Kimura Takara Bio Inc.

Responsible Party: Takara Bio Inc.
ClinicalTrials.gov Identifier: NCT03250325     History of Changes
Other Study ID Numbers: 1301-03
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
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

Keywords provided by Takara Bio Inc.:
Adoptive cell transfer
Cell therapy
Immunotherapy
NY-ESO-1
T cell receptor gene therapy
Synovial sarcoma

Additional relevant MeSH terms:
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