Clinical trial for safety and efficacy of NPT001-HTY in patients with curatively unresectable advanced or recurrent esophageal squamous cell cancer
Personalized cancer immunotherapy with neoantigen peptide-pulsed dendritic cells
Sasaki Hidetaka
NPT CO., LTD
3-5-7 Ariake, Koto-ku, Tokyo, Japan
+81-3-6455-7044
sasaki@neopt.jp
Sasaki Hidetaka
NPT CO., LTD.
3-5-7 Ariake, Koto-ku, Tokyo, Japan
+81-3-6455-7044
sasaki@neopt.jp
Pending
Feb. 01, 2025
12
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
<Primary confirmation of eligibility>
Subjects who meet all of the following items at the time of primary confirmation of eligibility will be eligible for this clinical trial.
1) Subjects who have received sufficient explanation about the contents of this trial and have given their written consent to participate in this trial
2) Subjects with curatively unresectable advanced or recurrent esophageal squamous cell cancer
3) Age at the time of informed consent: 18 to 74 years old
4) ECOG Performance Status (PS) at within 2 weeks from the time of informed consent: 0 or 1
5) Subjects with life expectancy at least 6 months at the time of informed consent
6) Subjects who are able to provide a sufficient amount of tumor tissue specimen and collect peripheral blood
<Secondary confirmation of eligibility>
Subjects who meet all of the following items at the time of secondary confirmation of eligibility will be eligible for this trial.
1) Subjects have given their written consent to continue this trial
2) Subjects with advanced or recurrent esophageal squamous cell carcinoma who are unresponsive or intolerant to standard treatments and who are unresectable
3) Subjects aged 75 years or younger at the time of secondary confirmation of eligibility
4) Subjects with lesions that can be evaluated by imaging test within 4 weeks before secondary confirmation of eligibility
5) Subjects with ECOG PS of 0 or 1 within 2 weeks prior to secondary confirmation of eligibility
6) Subjects with 5 or more types of neoantigen peptides as a result of neoantigen analysis and neoantigen peptide synthesis during the screening period
7) Subjects met with following laboratory tests.
WBC >= 3,000/mm^3
Neutrophil >= 1,000/mm^3
Hemoglobin >= 9.0 g/dL
Platelet>=10 x 10^4/mm^3
Total bilirubin <= 1.5 x upper limit of normal (ULN)
AST <= 2.5 x ULN
ALT <= 2.5 x ULN
Serum creatinine <= 1.5 mg/dL
8) Subjects judged as an ineligible by clinician in this trial
<Confirmation at the time of treatment transition>
Subjects who meet all of the following criteria at the time of treatment transition will be included in this clinical trial.
1) Subjects who have given written informed consent to continue in this clinical trial
2) Subjects with ECOG PS of 0 or 1 within 2 weeks prior to the treatment transition
<Primary confirmation of eligibility>
Subjects who meet any of the following criteria at the time of initial enrollment will be excluded from this clinical trial.
1) Subjects with systemic and active infections that are difficult to control (requiring systemic antibiotics, antifungals, or antivirals)
2) Subjects with synchronous or metachronous tumors other than esophageal cancer, or patients whose tumors have been cured but whose disease-free period has been less than 2 years (However, patients with intraepithelial or intramucosal cancer of the stomach or large intestine who can be judged to have been completely cured by endoscopic submucosal dissection (ESD), or patients with skin cancer who can be judged to have been completely cured by resection may be included)
3) Subjects with severe or difficult-to-control complications such as liver disease, kidney disease, heart disease, lung disease, brain disease, blood disease, or metabolic disease.
4) Subjects who are scheduled to receive any anti-cancer treatment during the main observation period or follow-up period
5) Subjects with a history of hypersensitivity to the bovine-derived ingredients, human serum albumin, human holotransferrin, HEK293 cells, and DMSO (dimethyl sulfoxide) which are used in the manufacture of the product, or subjects with drug allergies or a history of such allergies.
6) Subjects with a history of immunotherapy (tumor vaccines, cytokines, etc.) (excluding those with a history of immune checkpoint inhibitor treatment)
7) Subjects who are receiving other investigational products or investigational drugs (including clinical trial drugs) at the time of obtaining consent
8) Subjects who have previously undergone an organ transplant or who are scheduled to undergo an organ transplant during the clinical trial period
9) Female subjects who are pregnant, breastfeeding, or hoping to become pregnant between the time of obtaining informed consent and the end of the follow-up period, or female subjects who cannot agree to use highly effective contraception under the guidance of a doctor during the above period (even if breastfeeding, patients may be enrolled if they discontinue breastfeeding. However, breastfeeding is prohibited during the main observation period).
10) For male subjects, subjects who cannot agree to use highly effective contraception under the guidance of a doctor from the time of obtaining informed consent until the end of the follow-up period
11) Subjects who are otherwise deemed inappropriate for this clinical trial by the principal investigator or clinical investigator.
<Secondary confirmation of eligibility>
Subjects who meet any of the following criteria at the time of secondary confirmation of eligibility will be excluded from this clinical trial.
1) Subjects with systemic and active infections that are difficult to control (requiring systemic antibiotics, antifungals, or antivirals)
2) Subjects with synchronous or metachronous tumors other than esophageal cancer (However, patients with intraepithelial or intramucosal cancer of the stomach or large intestine who can be judged to be completely cured by ESD, or patients with skin cancer who can be judged to be completely cured by resection may be included)
3) Subjects with severe or difficult-to-control complications such as liver disease, kidney disease, heart disease, lung disease, brain disease, blood disease, or metabolic disease.
4) Subjects who are scheduled to receive any of the following treatments between the second confirmation of eligibility and the end of the follow-up period: anti-cancer drugs, systemic immunosuppressants, systemic corticosteroids, radiation therapy, immunotherapy, hyperthermia, and surgery (however, administration of immunosuppressants and corticosteroids for local effects, and localized radiation therapy for pain relief and removal of obstruction to the passage of food, etc., may be used concomitantly.)
5) Subjects with a history of immunotherapy (tumor vaccines, cytokines, etc.) (excluding those with a history of immune checkpoint inhibitor treatment)
6) Subjects who received other investigational products or investigational drugs (including clinical trial drugs) during the screening period
7) Subjects judged as an ineligible by clinician in this trial
<Confirmation at the time of treatment transition>
Subjects who meet any of the following criteria at the time of treatment transition will be excluded from this clinical trial.
1) Subjects with systemic and active infections that are difficult to control (requiring systemic antibiotics, antifungals, or antivirals)
2) Subjects with synchronous or metachronous tumors other than esophageal cancer (However, patients with intraepithelial or intramucosal cancer of the stomach or large intestine who can be judged to be completely cured by ESD, or patients with skin cancer who can be judged to be completely cured by resection may be included)
3) Subjects with severe or difficult-to-control complications such as liver disease, kidney disease, heart disease, lung disease, brain disease, blood disease, or metabolic disease.
4) Subjects who have received any of the following treatments after the secondary registration: anti-cancer drugs, systemic immunosuppressants, systemic corticosteroids, radiation therapy, immunotherapy, hyperthermia, or surgical therapy. Subjects who are scheduled to receive any of the following treatments between the time of transition to treatment and the end of the follow-up observation period. (However, the administration of immunosuppressants and corticosteroids for local effects, and localized radiation therapy for pain relief and removal of obstruction of passage, etc., may be used concomitantly.)
5) Subjects who received other investigational products or investigational drugs (including clinical trial drugs) during the period from secondary registration to the transition to administration
6) Subjects who are otherwise deemed inappropriate for this clinical trial by the principal investigator or clinical investigator
18age old over
75age old not
Both
Esophageal cancer
Administration of neoantigen peptide-pulsed dendritic cells.
Esophageal cancer
dendritic cells, vaccination
D004938
D014611
1) DLT, MTD
2) Safety
<Primary endpoint>
1) ORR, DCR, Best Overall Response (BOR)
2) PFS, OS
