Investigator-initiated Pilot Study to Investigate the Efficacy and Safety of Immuncell-LC in Combination With Nivolumab (Opdivo) in Subjects With Advanced or Recurrent Gastric Cancer

NCT05053295 | Unknown

• 1 other identifier: 3-2020-0356
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to evaluate the efficacy and safety of combination therapy of Immuncell-LC and nivolumab in patients with relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer.

Conditions

Relapsed or Advanced Gastric Adenocarcinoma; Gastro-esophageal Junction Cancer

Keywords

Immuncell-LC; Nivolumab; ILC-IIT-09; gastric adenocarcinoma,; gastro-esophageal junction cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) based on RECIST v1.1

  ORR is defined as the number of subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and expressed as a percentage of all treated participants.

  Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months after Last Patient In)

Secondary Outcomes (9)

• Overall survival (OS)

  Until death, follow-up failure or study discontinuation (Up to approximately 12 months after Last Patient In)

• Progression-free survival (PFS) based on RECIST v1.1

  Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)

• Duration of response (DOR) based on RECIST v1.1

  Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)

• Disease control rate (DCR) based on RECIST v1.1

  Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)

• ORR based on iRECIST

  Until disease progression, withdrawn, or initiation of subsequent chemotherapy (Up to approximately 12 months from the date the last subject was administered)

Study Arms (1)

Immuncell-LC/Nivolumab group

EXPERIMENTAL

Patients will receive nivolumab once a day at 4-week intervals and Immuncell-LC 12 times (3 treatments once a week, followed by 5 treatments every other week, and finally 4 treatments every 4 weeks).

Drug: autologous activated T lymphocyte

Interventions

autologous activated T lymphocyte DRUG

Drug: Immuncell-LC IV Drug: Nivolumab (Opdivo®) IV

Also known as: Immuncell-LC (Autologous activated T lymphocyte),

Immuncell-LC/Nivolumab group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males and females aged 19 years or above
• Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer that meets one of the following criteria:
• A. Confirmed relapsed or advanced gastric adenocarcinoma or gastro-esophageal junction cancer after at least two prior chemotherapies (Perioperative, neoadjuvant, and adjuvant chemotherapy are not considered as prior chemotherapies, but if the disease progression occurs during or within 6 months of completion of adjuvant chemotherapy, it is considered a prior chemotherapy).
• B. Patients who are not eligible for standard anti-cancer treatments due to contraindications, intolerance, etc. or who have no other standard treatments available for refusing the treatment may be enrolled at the judgement of the investigator regardless of the number of prior chemotherapies.
• A measurable lesion based on RECIST v1.1 (Irradiated area will be considered measurable if PD is confirmed in the area).
• The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1
• Life expectancy of at least 12 weeks
• Confirmed adequate hematological, hepatic, renal and coagulation functions as follows:
• A. Hematological function: absolute neutrophil count (ANC) ≥ 1,500/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100,000/μL B. Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit normal (ULN), total bilirubin ≤ 1.0 × ULN (if liver metastasis is confirmed, AST/ALT \< 3 × ULN) C. Renal function: blood urine nitrogen (BUN) and serum creatinine ≤ 1.5 × ULN D. Blood coagulation:prothrombin time (PT) (international normalized ratio, INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
• Fully understood the study information (purpose, procedure, etc.) and voluntarily provided a written consent to participate in this study.

You may not qualify if:

• \) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products
• \) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4
• \) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab
• \) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator
• \) History of anti-cancer treatment (chemotherapy, targeted therapy \[within 4 weeks for monoclonal antibody\], radiation therapy, etc.) within 2 weeks prior to screening
• \) An adverse event (AE) with prior treatments that is not resolved (CTCAE grade ≤ 1 or baseline) (with the exceptions of peripheral neuropathy or alopecia that are ≥ grade 2)
• \) History of immunosuppressive drugs within 2 weeks prior to screening (with the exceptions of topical, ophthalmic, intra-articular, intranasal, or inhalational corticosteroids, or systemic corticosteroids at doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid)
• \) Administration of live vaccines, live attenuated vaccines, or inactivated vaccines within 4 weeks prior to screening
• \) The following medical history confirmed at screening: A. Confirmed diagnosis of human immunodeficiency virus (HIV) (HIV 1/2 antibodies) which could worsen by immunotherapy B. History of an active immune disease (e.g. rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, vasculitis, multiple sclerosis, T cell lymphoma) with systemic treatment (disease controllers, corticosteroids, immunosuppressants, etc.) within 2 years prior to screening (Alternative therapies \[e.g., thyroxine, insulin, physiologic replacement therapy with corticosteroids for adrenal or pituitary insufficiency\] are not considered as systemic treatments) C. History of interstitial lung disease D. Concurrent infection or sepsis E. Evident myocardial failure or uncontrolled arterial hypertension F. Gastrointestinal perforation or fistula G. History of other malignant tumors excluding gastric adenocarcinoma/gastro-esophageal junction cancer within 5 years prior to screening (If the investigator determines that basal cell carcinoma/squamous cell carcinoma of the skin, localized prostate cancer, papillary thyroid carcinoma, or cervical carcinoma in situ is cured after successful treatment, the patients are eligible to participate even if 5 years have not passed)
• \) The following concomitant diseases at screening that may affect the safety and efficacy assessments during the study at the judgement of the investigator: A. Clinically significant pericardial effusion, pleural effusion or ascites (e.g., requiring treatment) B. Clinically significant symptoms or uncontrolled central nervous system or brain metastases or carcinomatous meningitis (except if progression is not confirmed clinically and on CT/MRI for at least 4 weeks before administration of the IP and treatment with steroids, etc. is not required for 7 days before administration of the IP after treatment of central nervous system or brain metastases.) C. Diseases that may clinically increase the risk of gastrointestinal bleeding (e.g., active diverticulitis, gastro-intestinal ulcerative disease or disease that can increase the risk of perforation) D. Active hepatitis B (HbsAg positive) or C (The patients are eligible to participate in the study even if HCV antibody is positive as long as RNA is negative, as it will be considered as a prior infection) E. Severe infections or other uncontrolled active infectious diseases requiring administration of antibiotics, antivirals, etc. that may affect the safety and efficacy assessments during the study F. Thromboembolic diseases or bleeding diatheses G. Considered ineligible to participate in the study due to concomitant disease that is uncontrolled or requires treatment (e.g., heart disease, decreased lung function, decreased kidney function, hypotension, hypertension, findings of myelosuppression, hepatitis, liver cirrhosis, history of alcohol addiction, myocardial infarction)
• \) Pregnant or breast-feeding women, or women who intend to become pregnant
• \) Received other IP or used an investigational device within 4 weeks prior to screening
• \) Ineligible or unable to participate in the study at the judgement of the investigator

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

Gangnam Severacen Hospital

Seoul, seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jae Yong Cho

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Yong Cho

CONTACT

82-2-2019-4601; CHOJY@yuhs.ac

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: Professor

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 22, 2021
• Study Start: July 2, 2021
• Primary Completion: July 1, 2023
• Study Completion: September 30, 2023
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)