Clinical trialNARecruiting
Anti-Mesothelin CAR-T Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
Exploratory 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
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 15 October 2024
- Expected end
- 14 October 2027
- Enrollment
- 24 participants
- Sites
- 1
- Primary outcomes
- Adverse Events (AEs); Serious Adverse Events (SAEs); Adverse Events of Special Interest (AESI); dentification of Maximum Tolerated Dose (MTD) & Incidence of Dose-limiting Toxicities (DLTs)
- Sponsor
- Other
- Results posted
- No
- Last update
- 8 June 2025
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Brief summary 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 cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Detailed description public domain (ClinicalTrials.gov)
In this study, patients with advanced malignant solid tumors with positive MSLN expression will be included. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by Anti-MSLN CAR-T cell injection. The dose escalation phase will determine the maximum tolerated dose (MTD) of Anti-MSLN CAR-T cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of Anti-MSLNCAR-T cell injection, and establish recommended phase 2 dose (RP2D).