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drugset / Trial / NCT07395479

A Platform Study of In Vivo CAR-T for Treating Advanced Malignant Tumors Based on Target Screening

NCT07395479 ↗

Phase 0 Recruiting 50 enrolled Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a single-arm, open-label, single-center, dose-escalation Phase I platform study designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and pharmacodynamics of an in vivo CAR-T therapy (V001 Injection, targeting BCMA, GPRC5D, DLL3,FcRH5, etc.) in patients with advanced malignant tumors.

Timeline

Start
2025-11-21
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject V001-BCMA Cell therapy 1e+08 unknown Intravenous
Subject V001-BCMA Cell therapy 2e+08 unknown Intravenous
Subject V001-BCMA Cell therapy 4e+08 unknown Intravenous
Subject V001-BCMA Cell therapy 8e+08 unknown Intravenous
Subject V001-DLL3 Cell therapy 1e+08 unknown Intravenous
Subject V001-DLL3 Cell therapy 2e+08 unknown Intravenous
Subject V001-DLL3 Cell therapy 4e+08 unknown Intravenous
Subject V001-DLL3 Cell therapy 8e+08 unknown Intravenous
Subject V001-FcRH5 Cell therapy 1e+08 unknown Intravenous
Subject V001-FcRH5 Cell therapy 2e+08 unknown Intravenous
Subject V001-FcRH5 Cell therapy 4e+08 unknown Intravenous
Subject V001-FcRH5 Cell therapy 8e+08 unknown Intravenous
Subject V001-GPRC5D Cell therapy 1e+08 unknown Intravenous
Subject V001-GPRC5D Cell therapy 2e+08 unknown Intravenous
Subject V001-GPRC5D Cell therapy 4e+08 unknown Intravenous
Subject V001-GPRC5D Cell therapy 8e+08 unknown Intravenous

Indications

cancer