Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Esophageal Neoplasms

Sarcoma

Melanoma

Head and Neck Neoplasms

Sarcoma, Synovial

Ovarian Cancer

Ovarian Epithelial Cancer

Esophageal Cancer

Soft Tissue Sarcoma

Synovial Sarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunomodulating Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

TBI-1301(5\*10\^8) single-dose administration with pre-treatment of cyclophosphamide alone.

TBI-1301(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide alone.

TBI-1301(5\*10\^9) single-dose administration with pre-treatment of cyclophosphamide and fludarabine.

Arm1, 2 or 3, which is considered as optimal.

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

TBI-1301

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.

Hiroshi Shiku, M.D., Ph.D.

Shinichi Kageyama, M.D., Ph.D.

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.

Following pre-treatment with cyclophosphamide alone or in combination with fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to HLA-A\*02:01 or HLA-A\*02:06 positive patients with solid tumors which are 1) unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc), and 2) NY-ESO-1-expressing. The primary objective is to evaluate the safety and in vivo kinetics, and the secondary is to evaluate clinical effect.

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

• Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigator Initiated Phase 1 Study of TBI-1301	NCT02366546	Solid Tumors	TBI-1301 Cyclophosphamid... Fludarabine	20 Years -	Mie University
Investigator Initiated Phase 1 Study of TBI-1301	NCT02366546	Solid Tumors	TBI-1301 Cyclophosphamid... Fludarabine	20 Years -	Mie University

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