Investigator Initiated Phase 1 Study of TBI-1301

Phase 1

Completed

• Conditions: Solid Tumors

• Registration Number: JPRN-jRCT2080222844
• Lead Sponsor: Mie University, Aichi Medical University, Keio University, National Cancer Center Hospital East, National Cancer Center Hospital, National Hospital Organization Nagoya Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-13
• Study Completion: 2018-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1) Histologically or cytologically confirmed solid tumors
2) Solid tumor, which is unresectable, refractory to standard therapy (chemotherapy, radiotherapy, etc.)
3) HLA-A*02:01 or HLA-A*02:06 positive
4) NY-ESO-1-expression by immunohistochemistry or PCR
5) ECOG Performance Status, 0 or 1
6) Age >=20 years on consent
7) No treatment (surgery, chemotherapy, radiotherapy, etc.) and expected sufficient recovery from the treatment at the time of the lymphocytes collection for gene transfer.
8) Life expectancy >= 16 weeks after consent
9) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria:
WBC >= 2,500/mm^3
Hemoglobin >= 8.0g/dL
Platelets >= 75,000/mm^3
T. billirubin < 1.5 x ULN
AST(GOT), ALT(GPT) < 3.0 x ULN
Creatinine < 1.5 x ULN
10) Ability to understand the study contents and to give a written consent at his/her free will.

Exclusion Criteria

1) 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
2) Serious hypersensitivity
3) Tumor cell invasion into CNS
4) Active multiple cancer
5) Positive for HBs antigen or HBV-DNA observed in serum, or 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) Percutaneous Oxygen saturation: < 94%
9) History of serious hypersensitivity reactions to bovine or murine derived substances
10) History of hypersensitivity reaction to drugs used in this study
11) Psycological disorder or drug dependency which may have impact on the consent.
12) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control after the consent during the study
13) Clinically significant systemic illness that in the judgment of the PI or subinvestigator would compromise the patient's ability to tolerate protocol therapy or significantly increase the risk of complications.

Study & Design

• Study Type: Interventional
• Study Design: Not specified