Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor

NCT03093688 | Recruiting Phase 1

• 1 other identifier: iNKT20170215V1.2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.

Conditions

Non-small Cell Lung Cancer; Small Cell Lung Cancer; Pancreas Cancer; Hepatocellular Carcinoma; Gastric Cancer; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events related to the infusion of cells

  The incidence of adverse events following infusion of iNKT cells and CD8+T cells

  28 days post-infusion

• Objective Response Rate (ORR)

  Change of target focus confirmed by CT or MRI

  up to 4 months post-infection

Secondary Outcomes (4)

• Hematologic analysis

  Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment

• Liver biochemical examination

  Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment

• Kidney biochemical examination

  Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment

• Tumor Marker

  Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment

Other Outcomes (1)

• Progression-Free Survival (PFS)

  Approximately 1 years after the treatment

Study Arms (1)

treatment

EXPERIMENTAL

The eligible patient receive the experimental infusion of iNKT cells and CD8+T cells .

Biological: Infusion of iNKT cells and CD8+T cells

Interventions

Infusion of iNKT cells and CD8+T cells BIOLOGICAL

The eligible patients receive twice infusions of iNKT cells(1E8\~1E10) and CD8+T cells(1E7\~1E9) in one course of treatment.

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytologically diagnosis of advanced lung cancer, or advanced gastric cancer, or advanced pancrease cancer, or hepatocellular carcinoma, or advanced colorectal cancer
• Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology
• Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal
• No dyspnea at rest. Oxygen saturation ≥90% on room air
• No genetic disease
• Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days
• Patients must have a Karnofsky performance status greater than or equal to 80%
• Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure
• Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion

You may not qualify if:

• Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure.
• Suffering from lymphoma or leukemia
• Serious infections requiring antibiotics, bleeding disorders
• Patients with myelodysplastic syndrome (MDS)
• History of immunodeficiency disease or autoimmune disease
• Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment
• Within concurrent chemotherapy
• Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
• Pregnant or breast-feeding patients
• Can't give informed consent
• Lack of availability for follow-up assessment

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

Related Publications (2)

• Wang J, Cheng X, Jin Y, Xia B, Qin R, Zhang W, Hu H, Mao X, Zhou L, Yan J, Zhang X, Xu J. Safety and Clinical Response to Combined Immunotherapy with Autologous iNKT Cells and PD-1+CD8+ T Cells in Patients Failing First-line Chemotherapy in Stage IV Pancreatic Cancer. Cancer Res Commun. 2023 Jun 7;3(6):991-1003. doi: 10.1158/2767-9764.CRC-23-0137. eCollection 2023 Jun.

  PMID: 37377605 DERIVED

• Cheng X, Wang J, Qiu C, Jin Y, Xia B, Qin R, Hu H, Yan J, Zhang X, Xu J. Feasibility of iNKT cell and PD-1+CD8+ T cell-based immunotherapy in patients with lung adenocarcinoma: Preliminary results of a phase I/II clinical trial. Clin Immunol. 2022 May;238:108992. doi: 10.1016/j.clim.2022.108992. Epub 2022 Mar 30.

  PMID: 35367396 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Pancreatic Neoplasms; Carcinoma, Hepatocellular; Stomach Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Liver Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Qing J Xu, M.D. Ph.D

  Shanghai Public Health Clinical Center

  STUDY CHAIR

Central Study Contacts

Yan X Zhang, M.D.

CONTACT

0086-021-37990333; zhangxiaoyan@shaphc.org

Recruiting

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Shanghai Emerging and Re-emerging Infectious Diseases Institute

Model Details: treatment group: receive twice cell infusions in one course of treatment.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 28, 2017
• Study Start: March 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)