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Investigator Initiated Phase 1 Study of TBI-1301

NCT02366546 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2018-10-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TBI-1301

TBI-1301(5\*10\^8 or 5\*10\^9) is administered.

DRUG

Cyclophosphamide

Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.

DRUG

Fludarabine

Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1301 in combination with cyclophosphamide.

Sponsors & Collaborators

  • Takara Bio Inc.

    collaborator INDUSTRY

  • Shionogi

    collaborator INDUSTRY

  • Fiverings Co., Ltd.

    collaborator OTHER

  • Statcom Co. Ltd.

    collaborator UNKNOWN

  • Mie University

    lead OTHER

Principal Investigators

  • Hiroshi Shiku, M.D., Ph.D. · Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital

  • Shinichi Kageyama, M.D., Ph.D. · Department of Immuno-Gene Therapy, Mie University, Graduate School of Medicine Mie University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-09-30

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366546 on ClinicalTrials.gov