To evaluate the efficacy, safety of Immuncell-LC in combination with Nivolumab in subjects with advanced gastric cancer

An Open-label, Single-arm, Single-center, Investigator-initiated Pilot Study to Investigate the Efficacy, Safety of Immuncell-LC in Combination with Nivolumab (Opdivo®) in Subjects with Advanced or Recurrent Gastric Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0005542

Enrollment

Registered

2020-10-27

Start date

2021-07-15

Completion date

Unknown

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : The investigational product (IP) will be administered until progressive disease (PD), unacceptable toxicity, consent withdrawal, or initiation of subsequent anti-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Adult males and females aged 19 years or above 2) Histologically and/or cytologically confirmed unresectable advanced/relapsed gastric adenocarcinoma or gastro-esophageal junction cancer subjects 3) A measurable lesion based on RECIST v1.1 4) The Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1 5) Life expectancy of at least 12 weeks 6) Confirmed adequate hematological, hepatic, renal and coagulation functions

Exclusion criteria

Exclusion criteria: 1) Prior treatment with any cell therapy products including but not limited to Immuncell-LC or natural killer (NK) cell therapy products 2) Prior immuno-oncology agents such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, and anti-CTLA-4 3) Hypersensitivity to the active ingredient or excipients of Immuncell-LC or nivolumab 4) Unable to collect autologous blood for production of Immuncell-LC at the judgement of the investigator 5) History of anti-cancer treatment within 2 weeks prior to screening 6) An adverse event (AE) with prior treatments that is not resolved 7) History of immunosuppressive drugs within 2 weeks prior to screening 8) Administration of live vaccines, live attenuated vaccines, or inactivated vaccines within 4 weeks prior to screening 9) Serious medical history confirmed at screening 10) Concomitant diseases at screening that may affect the safety and efficacy assessments during the study at the judgement of the investigator 11) Pregnant or breast-feeding women, or women who intend to become pregnant 12) 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

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR) based on RECIST v1.1	—

Secondary

Measure	Time frame
Overall survival (OS), Progression-free survival (PFS) and Duration of response (DOR) and Disease control rate (DCR) based on RECIST v1.1, ORR and PFS and DOR and DCR based on iRECIST	—

Countries

Korea, Republic of

Contacts

Public ContactJae Cho

Yonsei University Health System, Gangnam Severance Hospital

chojy@yuhs.ac+82-2-2919-4604

Outcome results