Clinical trialPhase 1Unknown
UCLM802 (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 UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Unknown
- Study type
- Interventional
- Start
- 27 April 2023
- Expected end
- July 2025
- Enrollment
- 87 participants
- Sites
- 1
- Primary outcomes
- Adverse Events (AEs); Serious Adverse Events (SAEs); Adverse Events of Special Interest (AESI); Identification of Maximum Tolerated Dose (MTD)
- Sponsor
- Other
- Results posted
- No
- Last update
- 12 May 2023
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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 UCLM802 (Anti-Mesothelin CAR-T) cell injection in patients with Mesothelin-positive advanced malignant solid tumors.
Detailed description public domain (ClinicalTrials.gov)
This study comprises a dose-escalation component and a dose-expansion component. In dose escalation phase, this study will adopt accelerated titration and 3+3 design to reduce the number of subjects exposed to potentially ineffective doses who may not benefit from treatment. In dose expansion phase, 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 on safety, tolerability and efficacy; Cohort 3: To explore the effects of combination immune checkpoint inhibitors on safety, tolerability and efficacy. All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection.