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

April 5, 2024 updated by: CHABiotech CO., Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • CHA Bundang Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female adults aged 19 years and older
  2. 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
  3. Life expectancy 6 months
  4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT101 q2w
CBT101 cells, every 2 weeks
Biological: CBT101 cells, every 2 weeks
CBT101 cells, every 4 weeks
Experimental: CBT101 q4w
CBT101 cells, every 4 weeks
Biological: CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose limiting toxicity (DLT)
Time Frame: 29 days
Dose limiting toxicity (DLT)
29 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival rate (DFS)
Time Frame: 6 months
Disease-free survival rate (DFS)
6 months
Oerall survival rate (OS)
Time Frame: 6 months
Oerall survival rate (OS)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHABiotech CO., Ltd

Investigators

  • Principal Investigator: Chan Kim, CHA Bundang Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Actual)

October 26, 2021

Study Completion (Actual)

October 26, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CBT101_P1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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