NCT07395479

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

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, etc.) in patients with advanced malignant tumors.

Detailed description

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, etc.) based on a lentiviral vector platform in patients with advanced malignant tumors (including hematological malignancies and solid tumors). The study employs a platform design, enrolling patients into different cohorts based on target and indication.

Conditions

• Advanced Malignant Tumours

Interventions

Type	Name	Description
GENETIC	V001-BCMA	An in vivo CAR-T drug targeting BCMA administered intravenously
GENETIC	V001-GPRC5D	An in vivo CAR-T drug targeting GPRC5D administered intravenously
GENETIC	V001-DLL3	An in vivo CAR-T drug targeting DLL3 administered intravenously

Timeline

• Start date: 2025-11-21
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China