Phase I Study on Tolerability, Safety and Efficacy of Combination Therapy of iPS-NKT Cell and Autologous DC/Gal in patients with Recurrent or Advanced Head and Neck Cancer - Combination therapy of iPS-NKT cell and DC/Gal

Iinuma Tomohisa0 sites6 target enrollmentMarch 29, 2023

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Iinuma Tomohisa
Enrollment: 6
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 29, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Iinuma Tomohisa

Eligibility Criteria

Inclusion Criteria

•Patients who meet all of the following criteria are eligible
•1\) Patients with recurrent or advanced head and neck cancer that is refractory or intolerant to standard therapy and who have evaluable disease that can be treated with intra\-arterial injection of iPS\-NKT cells.
•2\) Patients who are expected to have at least 1 month between prior therapy and the start of study treatment. The type of previous treatment is not required.
•3\) Patients must be between 20 and 80 years of age at the time of consent.
•4\) Patients with an ECOG performance status of 2 or less.
•5\) Patients with the following laboratory data.
•Hemoglobin \>\= 10 g/dL
•White blood cell count \>\= 3,000/uL, platelet count \>\= 75,000/uL
•Serum creatine\<\= 1\.5 mg/dL
•Total bilirubin \<\=1\.5 mg/dL, AST (GOT), ALT (GPT) \<\=2\.5 times the upper limit of the institutional standard

Exclusion Criteria

•Patients who meet any of the following conditions are not eligible
•1\) Patients who are HBs, HCV, HIV or HTLV\-1 antibody\-positive or HTLV\-1 antibody\-negative but have HBV\-DNA detected by HBV\-DNA quantitative testing.
•2\) Patients who have been taking or injecting corticosteroids (methylprednisolone 10 mg/day or higher or equivalent) or immunosuppressive drugs within at least 2 weeks prior to the start of the study product.
•3\) Female patients who are pregnant, lactating, or planning to become pregnant during the study. In the case of male and female with the potential to become pregnant, those who do not agree to total abstinence (Sexual intercourse between individuals of different biological genders) during the study period and up to 14 days after the last dose of the study product. (The total abstinence, however, does not apply if bilateral fallopian tube occlusion or partner vasectomy has already been performed on a patient before obtaining consent for this study.)
•4\) Patients with active autoimmune disease requiring systemic or immunosuppressive therapy with corticosteroids or biologic agents.
•5\) Patients who have experienced immune\-related adverse events with immune checkpoint inhibitors.
•6\) Patients with poorly controlled diabetes mellitus.
•7\) Patients with severe or more severe lung disease (mMRC Breathlessness Scale Grade 2 or higher) or with a history of non\-infectious interstitial lung disease requiring steroid treatment.
•8\) Patients with significant cardiac disease (NYHA class III or greater).
•9\) Patients with concurrent multiple cancers or patients who underwent aggressive treatment within 2 years prior to the first dose of study treatment. Radically resected basal cell carcinoma or squamous cell carcinoma of the skin, radically resected non\-invasive mammary ductal carcinoma or non\-invasive breast cancer, and radically resected upper gastrointestinal carcinoma by endoscope were excluded.