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OpenTrials
Completed

NCT Number: NCT04557306

Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer

The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer

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Key information

Conditions

Solid Tumor

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female adults aged 19 years and older
  • Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy
  • Life expectancy 6 months
  • Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1

Exclusion criteria

  • History of leptomeningeal carcinomatosis or spinal cord compression
  • History of peritoneal carninomatosis
  • Hemoglobine less than 9.0g/dL
  • Absolute Neutrophil Count (ANC) less than 1.5x10^3/mm^3
  • Platelet count less than 75x10^9/L
  • Total bilitbinn grater than 1.5 times te upper limit of normal
  • Alanine amino transferase (ALT) greater than 3 times the upper limit of normal
  • Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal
  • Uncontrolled hypertension
  • Intensive insuline therapy
  • Active infectious disease
  • Patients with hypersensitivity history or allergy to investigational product
  • Pregmant of lactating woman
  • Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial
  • Patients judged to be inappropriate for this study by the investigator with other reasons

Treatment and study plan

CBT101 cells, every 2 weeks

Biological

CBT101 cells, every 4 weeks

CBT101 cells, every 4 weeks

Biological

CBT101 cells, every 4 weeks

Primary outcomes

  1. Dose limiting toxicity (DLT)

    Time frame: 29 days

    Dose limiting toxicity (DLT)

Secondary outcomes

  1. Disease-free survival rate (DFS)

    Time frame: 6 months

    Disease-free survival rate (DFS)

  2. Oerall survival rate (OS)

    Time frame: 6 months

    Oerall survival rate (OS)

Sponsors and collaborators

Lead sponsor

CHABiotech CO., Ltd

Industry

Registry information

Official study title

An Open, 3+3 Design With Dose De-escalation, Single-center, Phase 1 Trial to Evaluate Tolerabiility and Safety of Intravenously Administered CBT101, an Autologous Natural Killer Cell, in Patients Who Underwent Curative Surgery and Adjuvant Therapy for Solid Cancer

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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