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RECRUITING
NCT05693844
PHASE1/PHASE2

Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.

Official title: Phase I/II Study of Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-01-20

Completion Date

2026-12-31

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pan-T booster co-expressing MSLN CAR T cell

Starting Dose: 1×10\^6 cells/kg

DRUG

Albumin-bound paclitaxel

Administered intravenously at dose of 100-200mg/m2 on day -5

DRUG

Cyclophosphamide

Administered intravenously at a total dose of 15-30mg/kg on day -3 and day -2

DRUG

Fludarabine

Administered intravenously at dose of 30mg/m2/d on day -3 and day -2

Locations (1)

Kaichao Feng

Beijing, Beijing Municipality, China