Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-02 @ 1:22 AM
Study NCT ID:
NCT05775666
Status:
UNKNOWN
Last Update Posted:
2023-03-20
First Post:
2023-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UCLM802 (Anti-Mesothelin CAR-T) Cell Injection in Patients With Mesothelin-positive Advanced Malignant Solid Tumors
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 will include two parts, dose escalation phase (accelerated titration and 3+3 design) followed by a dose expansion phase (Cohort 1: Malignant mesothelioma; Cohort 2: Advanced malignant tumors of the digestive system; Cohort 3: Other advanced malignant solid tumors.).
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection.
The dose escalation phase will determine the maximum tolerated dose (MTD) of UCLM802 cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of UCLM802 cell injection, and establish recommended phase 2 dose (RP2D).
All eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by UCLM802 cell injection.
The dose escalation phase will determine the maximum tolerated dose (MTD) of UCLM802 cell injection. Additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of UCLM802 cell injection, and establish recommended phase 2 dose (RP2D).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: