NCT07239323

In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies

Intracellularly Prepared Chimeric Antigen Receptor T-cell Therapy Targeting CD19 for the Treatment of Relapsed/Refractory Hematological Malignancies

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.

Detailed description

This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory malignant hematological tumors. Upon enrollment, subjects will receive an intravenous infusion of the in Vivo CAR-T preparation. Following the infusion, subjects will be hospitalized for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 2 years to determine if the disease is under control.

Conditions

• B-Acute Lymphoblastic Leukemia
• B Cell Non-Hodgkin's Lymphoma
• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Invivo CAR-T	Patients were enrolled and given a single dose of CAR-T injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 2 years.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: China