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A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor

ConditionsTreatmentNeoantigenVaccineSolid Tumor Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This is a clinical study of personalized self-DC vaccine targeting neo-antigen (Neo-DC vaccine) in the treatment of advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-75 years.

Histologically or cytologically confirmed advanced solid tumor, with at least one tumor lesion measurable (basis RECIST1.1 standard).

HLA typing was HLA-A0201/1101/2402 (containing at least one of the typing, according to the central laboratory issued).

Paraffin-embedded tumor tissue sections or biopsy tumor tissues within 3 years (for tumors with easy sampling).

Disqualifiers

Pregnant or lactating women.

Patients with a history of severe immediate allergies to the cells and any drugs used in this study.

Those with a history of organ transplantation.

Known central nervous system metastasis.

Trial design

Design model

Single group

Treatments tested in this trial

  • DC Vaccine

    Drug

    Patients will receive Neo-DC vaccine infusion either by dose 1 (1×10\^7 cells/time) or dose 2 (5×10\^7 cells/time) every 7 days, four cell infusions are one treatment cycle. The dose limited toxity observation time is within 28 days after the first Neo-DC vaccine infusion. If the efficacy is evaluated as clinical benefit (CR/PR/SD) or immune unconfirmed progress ( iUPD), treatment cycle can be continued until the completion of four Neo-DC vaccine administrations or disease progression (iCPD by iRECIST) or start new anti-tumor treatment or stop treatment by other reasons.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events

The incidence and severity of adverse events

Time frame
Within 28 days after the first Neo-DC vaccine cell infusion

Secondary outcomes

1

Objective response rate (ORR)

The partial remission (PR) and complete remission rate (CR)

Time frame
up 2 years
2

Dose limited toxicity

Dose limited toxicity within 28 days after the first Neo-DC vaccine cell infusion

Time frame
Within 28 days after the first Neo-DC vaccine cell infusion

Other outcomes

1

IFN-γ activity detected by ELISPOT, cell factor and T cell subsets detection.

IFN-γ activity detected by ELISPOT, cell factor detected by ELISA, and T cell subsets detection by flow cytometry.

Time frame
up 2 years
2

iDCR

iDCR by iRECIST

Time frame
up 2 years
3

iPFS

iPFS by iRECIST

Time frame
up 2 years
4

iDOR

iDOR by iRECIST

Time frame
up 2 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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