Health TrialsbyHealthPanel

Mesothelin/GPC3/GUCY2C-CAR-T Cells Against Cancers

ConditionsPancreas CancerCAR-T Cell TherapyMesothelinSolid Tumor, Adult
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital of Guangzhou Medical University

About this trial

The second generation of mesothelin targeted CAR-T cells that secret a fusion protein of IL21 and scfv against PD1 have been constructed and their anti-cancer function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the CAR-T cells for immunotherapy of human cancer patients with Mesothelin expressions. In this phase I study, the safety, tolerance, and preliminary efficacy of the Mesothelin-CAR-T cell immunotherapy on human cancers will firstly be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Had accepted gene therapy before;

Severe virus infection such as HBV, HCV, HIV, et al;

Known HIV positivity;

Active infectious disease related to bacteria, virus,fungi,et al;

Trial design

Design model

Single group

Treatments tested in this trial

  • CAR-T cells

    Biological/Vaccine

    Transfer CAR-T cells into patients for anti-ancer therapy.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Number of Patients with Dose Limiting Toxicity

A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the Mesothelin-CAR T cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.

Time frame
six months

Secondary outcomes

1

Percent of Patients with best response as either complete remission or partial remission.

Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.

Time frame
six months
2

Median CAR-T cell persistence

Median CAR-T cell persistence will be measured by quantitative rt-PCR.

Time frame
Six years

Other outcomes

Sponsors and contacts

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

Second Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Fapon Biotherapy Inc.

Collaborator

Source ClinicalTrials.gov
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