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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Biological: CBT101 cells, every 4 weeks; Biological: CBT101 cells, every 2 weeks

• Registration Number: NCT04557306
• Lead Sponsor: CHABiotech CO., Ltd

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-15
• Study First Submitted QC: 2020-09-15
• Study Start: 2020-09-21
• Study First Posted: 2020-09-21
• Primary Completion: 2021-10-26
• Study Completion: 2021-10-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CBT101 q4w	CBT101 cells, every 4 weeks	CBT101 cells, every 4 weeks
CBT101 q2w	CBT101 cells, every 2 weeks	CBT101 cells, every 2 weeks

Primary Outcome Measures

Name	Time	Method
Dose limiting toxicity (DLT)	29 days	Dose limiting toxicity (DLT)

Secondary Outcome Measures

Name	Time	Method
Oerall survival rate (OS)	6 months	Oerall survival rate (OS)
Disease-free survival rate (DFS)	6 months	Disease-free survival rate (DFS)

Trial Locations

Locations (1)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of