Clinical trialPhase 1Not yet recruiting
MSLN-targeted CAR-T Cells in Solid Tumors.
Anti-Mesothelin CAR-T Therapy in Subjects With Mesothelin-positive Advanced Malignant Solid Tumors.
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- April 2023
- Expected end
- April 2027
- Enrollment
- 87 participants
- Sites
- 0
- Primary outcomes
- Adverse Events (AEs); Serious Adverse Events; Adverse Events of Special Interest (AESI); Identification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
- Sponsor
- Other
- Results posted
- No
- Last update
- 24 March 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
This is a single-arm, open-label, exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of Anti-Mesothelin CAR-T cells. Patients will be confirmed to have sufficient expression of mesothelin as part of a prescreening. The study comprises a dose-escalation component and a dose-expansion component. There are three cohorts in dose-expansion component. Cohort 1: To explore the effects of different conditioning chemotherapy regimens on safety, tolerability and efficacy; Cohort 2: To explore the effects of different administration modes (intravenous injection and local injection) on safety, tolerability and efficacy; Cohort 3: To explore the effects of combination immune checkpoint inhibitors on safety, tolerability and efficacy.