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RECRUITING
NCT05631886
PHASE1

Combination of CAR-DC Vaccine and ICIs in Malignant Tumors

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This is a pilot clinical trial for subjects with local advanced/metastatic solid tumors or relapsed/refractory (R/R) lymphomas to determine the safety, efficacy and immune response of autologous EphA2-targeting CAR-DC vaccine loaded with TP53 mutant peptide (TP53-EphA-2-CAR-DC) in combination with ICIs. It aims to: assess the safety and antitumor effects of TP53-EphA-2-CAR-DC vaccine; detect T cell response against TP53 mutant peptide and tumor neoepitopes after the treatment with TP53-EphA-2-CAR-DC vaccine and ICIs.

Official title: A Pilot Clinical Trial of Autologous EphA-2-Targeting Chimeric Antigen Receptor Dendritic Cell Vaccine Loaded With TP53 Mutant Peptide Plus ICIs for Local Advanced/Metastatic Solid Tumors or Relapsed/Refractory Lymphomas.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2023-07-04

Completion Date

2026-12-30

Last Updated

2023-08-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

TP53-EphA-2-CAR-DC

5\~10 × 10\^6 CAR DCs per dose will be administered by intravenous injection.

DRUG

Abraxane

Intravenous abraxane 125 mg/m\^2/day on day-5.

DRUG

Cyclophosphamide

Intravenous cyclophosphamide 300 mg/m\^2/day on day -4.

DRUG

anti-PD-1 antibody

Intravenous anti-PD-1 antibody 200 mg/day.

DRUG

Anti-CTLA4 Monoclonal Antibody

Intravenous anti-CTLA4 antibody 1 mg/kg/day

Locations (1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, China