NCT06327997

An Exploratory Study by Fast CAR T Cells

Exploratory Study on the Treatment of Advanced Solid Tumor With Non-viral Vector Multi-targeted Autosecretory Multifunctional Antibody CAR-T Cell Injection
Shanghai Cell Therapy Group Co.,Ltd·Phase 1·ClinicalTrials.gov·biologicalRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Solid Tumor
Drug/Device/Intervention
Fast CAR T cells
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Shanghai Cell Therapy Group Co.,Ltd
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 1
Start date
Mar 07, 2024
End date
Dec 31, 2027
Enrollment
20 participants
Primary outcome

Dose-limiting toxicity(DLT)

Summary

The main goal of this trial is to evaluate the safety and tolerability of CAR T cell therapy
 for advanced solid tumors with positive mesothelin and MUC1.Patients were screened,
 peripheral blood mononuclear cells (PBMC) were isolated from eligible patients, and cells
 were prepared. Pretreatment was performed within 5 days before infusion, and CAR T cells were
 infused on day 0 (the dose was determined according to the requirements of
 climbing/expansion). The safety intensive observation period was 28 days after infusion, and
 the clinical efficacy after infusion was evaluated on days 28-34. The follow-up observation
 and evaluation were carried out according to the follow-up visit point, and the follow-up
 period was 1 year. From the second year, the telephone follow-up period was entered.

ICD-10 classifications
Malignant neoplasm: Connective and soft tissue, unspecifiedCarcinoma in situ, unspecifiedMalignant neoplasm: ParametriumMalignant neoplasm of other connective and soft tissueMalignant neoplasm: Lip, unspecified, inner aspect
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06327997
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06327997 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Cell Therapy Group Co.,Ltd and is currently Recruiting. The study focuses on Solid Tumor. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.