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

NCT ID: NCT04557306

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-10-26

Brief Summary

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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

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT101 q2w

CBT101 cells, every 2 weeks

Group Type EXPERIMENTAL

CBT101 cells, every 2 weeks

Intervention Type BIOLOGICAL

CBT101 cells, every 4 weeks

CBT101 q4w

CBT101 cells, every 4 weeks

Group Type EXPERIMENTAL

CBT101 cells, every 4 weeks

Intervention Type BIOLOGICAL

CBT101 cells, every 4 weeks

Interventions

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CBT101 cells, every 2 weeks

CBT101 cells, every 4 weeks

Intervention Type BIOLOGICAL

CBT101 cells, every 4 weeks

CBT101 cells, every 4 weeks

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHABiotech CO., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chan Kim

Role: PRINCIPAL_INVESTIGATOR

CHA Bundang Medical Center

Locations

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CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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CBT101_P1

Identifier Type: -

Identifier Source: org_study_id

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