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

CHA Biotech

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Biological: CBT101 cells, every 2 weeks; Biological: CBT101 cells, every 4 weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT04557306

CBT101_P1

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

CBT101 q2w

Experimental group

Description:

CBT101 cells, every 2 weeks

Treatment:

Biological: CBT101 cells, every 2 weeks

CBT101 q4w

Experimental group

Description:

CBT101 cells, every 4 weeks

Treatment:

Biological: CBT101 cells, every 4 weeks