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Combination of CAR-DC Vaccine and ICIs in Malignant Tumors

NCT05631886 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-08-28

No results posted yet for this study

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.

Conditions

  • Solid Tumor, Adult
  • Lymphoma
  • EphA2 Overexpression
  • TP53 R273H
  • TP53 R175H
  • TP53 R248Q
  • TP53 R249S

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

Sponsors & Collaborators

  • Zhejiang University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yang Xu, Ph.D · Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-04
Primary Completion
2025-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631886 on ClinicalTrials.gov