Trials / Unknown
UnknownNCT05848999
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 87 (estimated)
- Sponsor
- Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | UCLM802 Cell Injection (Anti-mesothelin CAR-T cells) | D0: 0.1×106/Kg ～ 2.0×106/Kg; Cells will be infused intravenously. |
Timeline
- Start date
- 2023-04-27
- Primary completion
- 2025-05-01
- Completion
- 2025-07-01
- First posted
- 2023-05-08
- Last updated
- 2023-05-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05848999. Inclusion in this directory is not an endorsement.