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NOT YET RECRUITING
NCT07873476

Real-world Clinical Effectiveness & Safety LV009, an in Vivo CAR-T for the Treatment of Hematologic Cancers, Auto-immune Diseases & HLA/ AAV Sensitization.

Sponsor: Healthy Malaysia Association

View on ClinicalTrials.gov

Summary

The study objective is to determine the real-world safety and effectiveness of LV009 therapy for 3 potential indications: (1) refractory or relapsed hematologic cancers (acute lymphoblastic Leukemia, B cell Lymphomas, multiple myeloma), (2) auto-immune diseases, (3) de-sensitization of patients awaiting organ transplant or AAV-based gene therapy who have pre-existing anti-HLA or anti-AAV antibodies. This is an observational study designed to determine the real-world safety and effectiveness of LV009, an in vivo CAR-T therapy, among patients with hematologic cancers, auto-immune diseases, or HLA/AAV sensitization. Following the administration of LV009, patient will be monitored for toxicity and response to treatment. No subjects will be withdrawn from the study, and subjects could freely drop out from the study anytime, simply by not showing up. The study objective is to determine the real-world safety and effectiveness of LV009 therapy for 3 potential indications: (1) refractory or relapsed hematologic cancers (acute lymphoblastic Leukemia, B cell Lymphomas, multiple myeloma), (2) auto-immune diseases, (3) de-sensitization of patients awaiting organ transplant or AAV-based gene therapy who have pre-existing anti-HLA or anti-AAV antibodies.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-10-28

Completion Date

2031-12-31

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

GENETIC

LV009

LV009 is an improved third-generation lentiviral vector intended for intravenous administration to generate fully human anti-CD19/anti-BCMA CAR T cells in vivo. The vector is designed to target CD7- and CD3-positive T cells and natural killer (NK) cells, enabling in vivo delivery of the CAR transgene and cellular reprogramming. In this prospective observational study, patients receiving LV009 through early or expanded access use will be followed for real-world safety and clinical effectiveness across hematologic cancers, autoimmune diseases, and HLA/AAV sensitization

Locations (1)

Tzu Chi Hospital - Jakarta, DKI Jakarta, Indonesia 14470.

Jakarta, DKI Jakarta, Indonesia