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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02366546

Enrollment

Registered

2015-02-19

Start date

2015-03-31

Completion date

Unknown

Last updated

2018-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumors

Keywords

Adoptive cell transfer, Cell therapy, Immunotherapy, NY-ESO-1, Esophageal cancer, Melanoma, Head and neck cancer, Ovarian cancer, Synovial sarcoma, TCR gene therapy

Brief 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.

Detailed description

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.

Interventions

DRUGTBI-1301

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

DRUGCyclophosphamide

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

DRUGFludarabine

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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 PCR or immunohistochemistry 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/μL * Hemoglobin \>= 8.0g/dL * Platelets \>= 75,000/μL * T. bilirubin \< 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 6. Positive for HCV antibody and HCV-RNA observed in serum 7. Positive for antibodies against HIV or HTLV-1 8. Left Ventricular Ejection Fraction (LVEF): \<= 50％ 9. Percutaneous Oxygen saturation: \< 94％ 10. History of serious hypersensitivity reactions to bovine or murine derived substances. 11. History of hypersensitivity reaction to drugs used in this study. 12. Psychological disorder or drug dependency which may have impact on the consent. 13. 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 14. 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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence and grade of adverse events (CTCAE)	4 weeks	• Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Appearance of replication competent retrovirus by PCR	4 weeks	Confirm no replication competent retrovirus observed.
Appearance of clonality by LAM-PCR	4 weeks	Confirm no clonality is observed.
Kinetics of TBI-1301 in blood by realtime-PCR	8 weeks	Evaluate persistence and expansion of transferred TBI-1301.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026