Study of Autologous CIK Cell Immunotherapy Combination With PD-1 Inhibitor and Chemotherapy in the Advanced NSCLC

NCT03987867 | Unknown Phase 1

• 1 other identifier: E2019091A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, unicentric, open-labe phase I study is to evaluate the effects of autologous cytokine-induced killer cell immunotherapy combination with PD-1 inhibitor and chemotherapy in the first-line treatment of IIIB/IIIC/IV non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer; First-line Treatment

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR was calculated by the percentage of patients with a confirmed complete (CR) or partial response (PR).

  2 years

Study Arms (1)

Arm: CIK+PD-1 inhibitor+chemotherapy

EXPERIMENTAL

CIK cell, IBI308, Pemetrexed, Liposome paclitaxel, Carboplatin IBI308 intravenous infusion 200mg d1; Pemetrexed intravenous infusion 500mg/m2 d2 or Liposome paclitaxel intravenous infusion 135mg/m2 d2; Carboplatin intravenous infusion AUC5 d2; CIK cells, 1x10\^10 (10 billion ), intravenous infusion,d14; Q3W.

Biological: CIK cell; Biological: Sintilimab Injection; Drug: Pemetrexed; Drug: Liposome paclitaxel; Drug: Carboplatin

Interventions

CIK cell BIOLOGICAL

CIK cell injection

Also known as: Autologous cytokine-induced killer cells

Arm: CIK+PD-1 inhibitor+chemotherapy

Sintilimab Injection BIOLOGICAL

IBI308 injection

Also known as: PD-1 inhibitor

Arm: CIK+PD-1 inhibitor+chemotherapy

Pemetrexed DRUG

Pemetrexed injection

Arm: CIK+PD-1 inhibitor+chemotherapy

Liposome paclitaxel DRUG

Liposome paclitaxel injection

Arm: CIK+PD-1 inhibitor+chemotherapy

Carboplatin DRUG

Carboplatin injection

Arm: CIK+PD-1 inhibitor+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who must meet all the following criteria should be selected:
• Agreeing to participate in this study and signing a written informed consent.
• Male or female,from 18 to 75 years (including 18 and 75 years).
• The life expectancy will be longer than 3 months and can be followed up.
• Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
• Initial medical treattment.Patients with adenocarcinoma need wild type of EGFR gene and ALK fusion gene negative to be included in this study.
• ECOG score will be 0 or 1 within 7 days before randomization.
• Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:
• White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
• The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
• Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
• Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.

You may not qualify if:

• Subjects who meet any of the following criteria could not participate in this study:
• Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
• NSCLC that had received chemotherapy in the past.
• Other malignant tumors needed treatment within five years.
• Allogeneic tissue/organ transplantation.
• Participating in research drug therapy within 4 weeks before the first administration of the trial.
• Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
• Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
• Previous treatment with PD-1/PD-L1 antibodies.
• Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
• Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA \> 10\^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
• Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
• Patients with active infections requiring systemic intravenous therapy.
• Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
• Subjects who are known to be allergic to any of the constituents of the drug being studied.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

• Zhou L, Xiong Y, Wang Y, Meng Y, Zhang W, Shen M, Zhang X, Li S, Ren B, Li R, Han Y, Zhang J, Cao S, Du W, Sun Q, Wei F, An X, Yang L, Zhang Y, Ma W, Xu W, Zhang Y, Jiang J, Xu X, Xia J, Liu L, Ren X. A Phase IB Trial of Autologous Cytokine-Induced Killer Cells in Combination with Sintilimab, Monoclonal Antibody Against Programmed Cell Death-1, plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2022 Dec;23(8):709-719. doi: 10.1016/j.cllc.2022.07.009. Epub 2022 Jul 21.

  PMID: 35995696 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; Immune Checkpoint Inhibitors; Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Xiubao Ren, MD. PhD.

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Xiubao Ren, MD. PhD.

CONTACT

86-22-23340123; liangcoh@163.com

Liang Liu, MD. Ph.D

CONTACT

86-22-23340123; renxiubao@tjmuch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)