A Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Allogeneic iNKT Cell Infusion in Subjects With Advanced Pancreatic Cancer

NCT07055568 | Not Yet Recruiting

• 1 other identifier: 20250407033053070
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the preliminary safety and tolerability of iNKT cell injection after infusion in each group of subjects, and to determine the maximum tolerated dose (MTD) and/or the recommended dose for extended studies.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Safety

  After 28 days of infusion

• Maximum tolerated dose (MTD)

  tolerability

  After 28 days of infusion

Secondary Outcomes (6)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  About 2 years

• Antitumor efficacy-Objective response rate (ORR)

  About 2 years

• Antitumor efficacy-Duration of response (DOR)

  About 2 years

• Antitumor efficacy-Disease control rate (DCR)

  About 2 years

• Antitumor efficacy-Progression-free survival (PFS)

  About 2 years

Study Arms (1)

iNKT

EXPERIMENTAL

Drug: iNKT

Interventions

iNKT DRUG

iNKT: Intravenous infusion, 0.5×10\^8cell-3.0×10\^8 cell

iNKT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily participate in clinical research; Fully understand this study and voluntarily sign the informed consent form; Willing to follow and capable of completing all the test procedures;
• \. Male or female, aged 18 to 75 years old (including the boundary value);
• \. Patients with locally advanced or metastatic pancreatic cancer confirmed by histology or cytology. Patients with locally advanced or metastatic pancreatic cancer that cannot be surgically resected and have failed standard first - or second-line treatments, or have intolerable toxic and side effects of the existing standard treatments, or are not applicable to standard treatments at the present stage, or refuse standard treatments;
• \. According to RECIST version 1.1, there is at least one evaluable tumor lesion;

You may not qualify if:

• \. Have sufficient organ functions;
• \. The physical condition score of the Eastern Cooperative Oncology Group (ECOG) in the United States was 0-1;
• \. The expected survival period is more than 3 months;
• \. Premenopausal female subjects had negative blood pregnancy results before the start of the study treatment and were willing to abstain from sex or take medically recognized effective contraceptive measures (such as intrauterine devices, condoms) within 6 months from the signing of the informed consent form until the end of the last infusion;
• \. Male subjects are willing to abstain from sexual activity or take medically recognized effective contraceptive measures for 6 months from the date of signing the informed consent form until the end of the last infusion, and not donate sperm during this period.
• \. Participate in clinical trials of other drugs within 30 days before the first infusion;
• \. Within 30 days before the first infusion, there is a history of allogeneic or autologous T cell, NK cell and other cell therapy;
• \. Allergic to any component of iNKT cell injection;
• \) The following treatments or drugs were received before the first infusion:The use of systemic corticosteroids or immunosuppressive drugs within 14 days before the start of the study treatment, excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, or receiving systemic steroid hormone replacement therapy at a dose equivalent to 10mg/d prednisone, Short-term (≤7 days) use of corticosteroids is permitted for prevention (such as allergy to contrast agents) or treatment of non-autoimmune conditions (such as delay-type hypersensitivity reactions caused by exposure to allergens); The attenuated live vaccine was administered within 30 days before the start of the research treatment;
• \. Brain metastasis or the presence of spinal cord compression;
• \. The subject is diagnosed with severe autoimmune diseases that require systemic immunosuppressants (including but not limited to: steroids) for treatment, or immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), and autoimmune vasculitis (e.g., Wegener's granulomatosis);
• \. Within 5 years prior to the first infusion, there have been other active malignant tumors, except for those malignant tumors that can be treated locally and have been cured (such as basal cell or squamous cell carcinoma of the skin, superficial or non-invasive bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, papillary thyroid carcinoma);
• \. Within 6 months before the first infusion, the following situations occur: transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris; Congestive heart failure classified as grade III or IV by the New York Heart Association (NYHA); Left ventricular ejection fraction \< 50%; Or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III atrioventricular block, etc. Or use a cardiac pacemaker; The electrocardiogram results show clinically significant abnormalities, or QTcF≥450ms (if the first examination is abnormal, retests can be conducted at least 5 minutes later, and the comprehensive result/average value can be taken to determine the qualification);
• \. There is a history of interstitial lung disease requiring hormone therapy in the past, or there is currently interstitial lung disease;
• \. There is effusion in the thoracic cavity, pericardium and peritoneal cavity;

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Jiang Long, MD

CONTACT

86+18017317460; jiang.long@shgh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician of hepatobiliary and pancreatic surgery

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 9, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07