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An Exploratory Study by Fast CAR T Cells - Trial NCT06327997

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.

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NCT06327997
Phase 1
Recruiting
biological
Trial Details
ClinicalTrials.gov โ€ข NCT06327997
View on ClinicalTrials.gov
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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

Study Focus

Solid Tumor

Fast CAR T cells

Interventional

biological

Sponsor & Location

Shanghai Cell Therapy Group Co.,Ltd

Shanghai, China

Timeline & Enrollment

Phase 1

Mar 07, 2024

Dec 31, 2027

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, unspecified
Carcinoma in situ, unspecified
Malignant neoplasm: Parametrium
Malignant neoplasm of other connective and soft tissue
Malignant neoplasm: Lip, unspecified, inner aspect

Data Source

ClinicalTrials.gov

NCT06327997

Non-Device Trial