drugset / Trial / NCT06327997

An Exploratory Study by Fast CAR T Cells

NCT06327997 ↗

Phase 0 Recruiting 20 enrolled Shanghai Cell Therapy Group Co.,Ltd
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-03-07
Primary completion
2027-03-06
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fast CAR T cells Cell therapy 500000 cells/kg —
Subject Fast CAR T cells Cell therapy 1e+06 cells/kg —
Subject Fast CAR T cells Cell therapy 5e+06 cells/kg —

Indications