RecruitingPhase 1NCT05631886

Combination of CAR-DC Vaccine and ICIs in Malignant Tumors

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.


Sponsor

Chinese PLA General Hospital

Enrollment

10 participants

Start Date

Jul 4, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new cancer treatment that combines a special immune cell vaccine (CAR-DC) with checkpoint inhibitor drugs (ICIs) in people with advanced or hard-to-treat cancers. The treatment is designed to help the immune system better recognize and fight cancer cells. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of advanced solid tumor or relapsed/refractory lymphoma - Your tumor has tested positive for certain proteins (EphA2 and TP53 mutation) - You are in reasonably good health with an expected survival of more than 3 months **You may NOT be eligible if...** - Your tumor does not have the required protein markers - You are in poor general health - You have certain other active cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTP53-EphA-2-CAR-DC

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

DRUGAbraxane

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

DRUGCyclophosphamide

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

DRUGanti-PD-1 antibody

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

DRUGAnti-CTLA4 Monoclonal Antibody

Intravenous anti-CTLA4 antibody 1 mg/kg/day


Locations(1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, China

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NCT05631886


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