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

Solid Tumor Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557306
• Other study ID #: CBT101_P1
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2020
• Est. completion date: October 26, 2021

Study information

• Verified date: February 2024
• Source: CHABiotech CO., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 26, 2021
• Est. primary completion date: October 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Biological:
• CBT101 cells, every 2 weeks
CBT101 cells, every 4 weeks
• CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
CHABiotech CO., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicity (DLT)	Dose limiting toxicity (DLT)	29 days
Secondary	Disease-free survival rate (DFS)	Disease-free survival rate (DFS)	6 months
Secondary	Oerall survival rate (OS)	Oerall survival rate (OS)	6 months