Health TrialsbyHealthPanel

Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors

ConditionMesothelin-positive Advanced Malignant Solid Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University

About this trial

This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cell injection in patients with Mesothelin-positive advanced malignant solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 75 years old (including cut-off value), gender is not limited.

Solid tumors that histological diagnosis of malignancy refractor to, or relapsing after standard therapy, including but not limited to mesothelioma, pancreatic cancer, biliary tract cancer, lung cancer, ovarian cancer, gastric cancer, bowel cancer, thymic carcinoma, esophageal cancer, breast cancer, endometrial cancer. Subjects have failed with standard treatment or cannot tolerate treatment recommended by clinical treatment guidelines form relevant international and domestic authoritative organization (Chinese Anti-Cancer Association(CACA), Chinese Society of Clinical Oncology(CSCO), National Health Commission, etc.)

At least one measurable lesion according to RECIST v1.1.

Mesothelin should be positive confirmed by Immunohistochemistry/Immunocytochemistry (IHC/ICC) in tumor tissue samples.

Disqualifiers

Pregnant or lactating women.

Patients with hepatitis B surface antigen (HBsAg) positive. Patients who is hepatitis B core antibody (HBcAb) positive and the quantification of HBV DNA in peripheral blood is higher than the lower limit of detection. Patients who is hepatitis C virus (HCV) antibody positive and quantification of HCV RNA in peripheral blood is higher than the lower limit of detection. Patients with human immunodeficiency virus (HIV) antibody positive, or syphilis antibody positive.

The toxicities caused by the prior therapy (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) have not recovered to grade 1 according to CTCAE, except for hair loss and peripheral sensory nerve disorders.

Have received any allogeneic tissue/organ transplantation (including bone marrow transplantation, stem cell transplantation, liver transplantation, kidney transplantation), except for the transplantation that does not require immunosuppressive therapy (such as: corneal transplantation, hair transplantation.)

Trial design

Design model

Single group

Treatments tested in this trial

  • Anti-mesothelin CAR-T cells

    Biological/Vaccine

    D0: 0.1×10\^6/Kg\~1.0×10\^6/Kg; cells will be infused intravenously.

  • Fludarabine

    Drug

    D-7 to D-3: Fludarabine (25 mg/m\^2/day) will be administered intravenously for 5 days.

  • Cyclophosphamide

    Drug

    D-7 to D-3: Cyclophosphamide (300 mg/m\^2/day) will be administered intravenously for 5 days.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Anti-mesothelin CAR-T cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Incidence and severity of adverse events.

Time frame
2 years
2

Serious Adverse Events (SAEs)

Incidence and severity of serious adverse events.

Time frame
2 years
3

Adverse Events of Special Interest (AESI)

Incidence and severity of adverse event of special interest.

Time frame
2 years
4

dentification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)

Incidence and severity of dose-limiting toxicities (DLTs) following infusion of CAR-T cell injection, at each dose level tested in dose escalation phase.

Time frame
4 weeks after the CAR-T cells infusion

Secondary outcomes

1

Objective Response Rate (ORR)

The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.

Time frame
2 years
2

Disease Control Rate (DCR)

Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.

Time frame
2 years
3

Duration of Overall Response (DOR)

Time from documentation of disease response to disease progression.

Time frame
2 years
4

Progression-Free Survival (PFS)

PFS is defined as the time from CAR-T infusion to the date of the disease progression or death from any cause.

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Zhejiang University

Lead sponsor

First Affiliated Hospital of Zhejiang University

Sponsor institution

UTC Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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