Health TrialsbyHealthPanel

MSLN-targeted CAR-T Cells in Solid Tumors.

ConditionMesothelin-positive Advanced Malignant Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This study aims to explore the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells in subjects with Mesothelin-positive advanced malignant solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is≥18 years old (including cut-off value), gender is not limited

Solid tumors that histological diagnosis of malignancy refractory 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.

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

Patients have received systemic therapy with cytotoxic chemicals, monoclonal antibodies, or immunotherapy within 4 weeks or 5 half-lives (which is shorter) prior to signing informed consent; Patients have received systemic glucocorticoids (prednisone at a dose of ≥10 mg per day or equivalent) or other immune-suppressive therapy within 2 weeks prior to signing informed consent; Patients have received systemic antitumor therapy with a biologic agent or other approved targeted small-molecule inhibitor within 1 week or five half-lives (which is shorter) prior to signing informed consent; Patients have received Chinese herbal medicine or Chinese patent medicine with anti-tumor indication within 1 week prior to signing informed consent.

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 DNA 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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Anti-mesothelin CAR-T cells

    Biological/Vaccine

    Anti-mesothelin CAR-T cells are autologous genetically modified T cells. Cells will be infused intravenously.

Treatment groups

87 Participants
are divided into 1 treatment group
Group A: Anti-mesothelin CAR-T cells InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events (AEs)

Incidence and severity of adverse events.

Time frame
2 years
2

Serious Adverse Events

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

Identification 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

Locations

This trial has no locations.

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

UTC Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: