A Phase I study of iPS-NKT cell intra-arterial infusion therapy in patients with recurrent or advanced head and neck cancer

JRCT ID: jRCT2033200116

Registered date:11/09/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Patients with recurrent or advanced head and neck squamous cell carcinoma
• Date of first enrollment: 11/09/2020
• Target sample size: 9
• Study type: Interventional
• Intervention(s): We do intra-tumor nutrient artery administration of iPS-NKT cells in patients with recurrent or advanced head and neck cancer after standard therapy, which is difficult to treat radically.

Outcome(s)

• Primary Outcome: Incidence of dose-limiting toxicity (DLT) at each dose

Secondary Outcome

Secondary efficacy endpoint
Response rate (RECIST ver.1.1)
Disease control rate (RECIST ver.1.1)

Secondary Safety Endpoints
Occurrence of adverse events (type, frequency, severity, etc.)
Changes in clinical laboratory values

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients who meet all of the following criteria will be eligible
1) Patients with recurrent or advanced head and neck squamous cell carcinoma, refractory or intolerant to standard treatment and who have evaluable lesions that can be treated with intra-arterial infusion to tumor.
2) Patients who have been on previous therapy for at least 1 month. Any type of previous treatment is acceptable.
3) Patient must be at least 20 years of age but less than 80 years at the time consent is obtained.
4) Patients must have an ECOG Performance Status of 2 or less.
5) Patients who meet the following laboratory data.
Hemoglobin >10 g/dL
White blood cell count >3,000/uL and 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 facility reference values
SpO2 (room air) >93%.
6) Patients who are expected to have a prognosis of 3 months or more.
7) Patients for whom written consent has been obtained from the individual.

Exclude 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 and male patients who do not intend to use any of the following effective contraceptive methods under the guidance of a physician during the study period or up to 14 days after the last dose of the study product.
<Effective method of contraception>
Oral hormonal contraceptives
Intrauterine contraceptives
Bilateral Fallopian tube occlusion
Vasectomy for my partner.
Total abstinence.
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.
10) Patients who are unable to use contrast media.
11) Patients with a history of hypersensitivity to human serum albumin products or proteins of foreign origin.
12) Patients who, at the time of consent acquisition, are participating in other clinical trials or clinical studies and are receiving other investigational products or are judged by the investigator or sub-investigator to have residual effects of adverse events caused by such products.
13)The genotypes of HLA-A, B and C are completely identical to those of the investigational product.
14) Patients who are judged by the attending physician to be unsuitable to participate in the study.

Related Information

• Primary Sponsor: Iinuma Tomohisa
• Secondary Sponsor: Motohashi Shinichiro
• Source(s) of Monetary Support: BrightPath Biotherapeutics Co., Ltd.,Japan Agency for Medical Research and Development