Trials / Unknown

UnknownNCT05461235

Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma

A Prospective, Open, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Anti-PD-1 Antibody Combined With Autologous DC and NK Cells in the Treatment of Digestive Carcinoma.

Status: Unknown
Phase: Phase 2
Study type: Interventional
Enrollment: 1 (estimated)

Sponsor: China Medical University, China · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

Detailed description

This is a prospective, open, single-arm Phase II clinical study to evaluate the efficacy and safety of anti-PD-1 antibody combined with autologous DC and NK cells in the treatment of digestive carcinoma. This project aims to enhance the anti-tumour activity of DC/NK cells in combination with anti-PD-1 antibodies, and ultimately activate the patient's own immune function to improve the quality of life and survival time of tumour patients, and provide objective evidence for the widespread use of targeted immune cell therapy in the clinical setting.

Conditions

Interventions

Type	Name	Description
DRUG	Pembrolizumab	2mg/kg or 200mg,iv,q3w
DRUG	Nivolumab	3mg/kg or 240mg,iv,q2w
DRUG	Sintilimab	200mg,iv,q3w
DRUG	Toripalimab	3mg/kg or 240mg,iv,q2w
DRUG	Camrelizumab	200mg,iv,q2w or q3w;3mg/kg,iv,q3w
DRUG	Tislelizumab	200mg,iv,q3w
BIOLOGICAL	NK-Cell or DC-Cell	50ml of peripheral blood was collected 1 day before the dosing cycle for in vitro isolation and amplification of DC and NK cells; the first transfusion of DC and NK cells (not less than 1x10\^6 cells/Kg) was completed on day 14.

Timeline

Start date: 2022-07-15
Primary completion: 2025-07-15
Completion: 2025-12-01
First posted: 2022-07-18
Last updated: 2022-07-18

Source: ClinicalTrials.gov record NCT05461235. Inclusion in this directory is not an endorsement.