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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04557306

Enrollment

Registered

2020-09-21

Start date

2020-09-21

Completion date

2021-10-26

Last updated

2024-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

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

Interventions

BIOLOGICALCBT101 cells, every 2 weeks

CBT101 cells, every 4 weeks

BIOLOGICALCBT101 cells, every 4 weeks

CBT101 cells, every 4 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Dose limiting toxicity (DLT)	29 days	Dose limiting toxicity (DLT)

Secondary

Measure	Time frame	Description
Disease-free survival rate (DFS)	6 months	Disease-free survival rate (DFS)
Oerall survival rate (OS)	6 months	Oerall survival rate (OS)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026