Observes real-world safety of LV009 gene-based cell therapy in blood cancers and autoimmune disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with relapsed or refractory blood cancers, certain autoimmune diseases, or anti-HLA or anti-AAV antibodies while waiting for an organ transplant or AAV-based gene therapy. They would receive LV009, an in vivo CAR-T therapy.

Sex

All sexes can join.

Disease stage

Refractory or relapsed acute lymphoblastic leukemia, B-cell lymphomas or multiple myeloma; or an autoimmune disease such as lupus (SLE), myasthenia gravis or multiple sclerosis; or anti-HLA or anti-AAV antibodies while on a wait list for an organ transplant or AAV-based gene therapy.

Biomarker or test result

Pre-existing anti-HLA or anti-AAV antibodies (for people on the transplant or gene therapy wait list).

Main reasons for not taking part

• Known active central nervous system (CNS) metastases
• Known hepatitis B or C or HIV infection
• Active infection or fever of 38°C (100.4 °F) or higher within 3 days of the first LV009 dose

The registry criteria, word for word

What the trial wants to find out

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 No subjects will be withdrawn from the study, and subjects could freely drop out from the study anytime, simply by not showing up.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.

The 3 groups in the trial

• Hematologic Cancer Cohort

  Participants with refractory or relapsed hematologic cancers, including acute lymphoblastic leukemia, B-cell lymphomas, or multiple myeloma, who receive LV009 and are followed prospectively for the safety and clinical effectiveness of LV009.

  Treatment: LV009

• Autoimmune Disease Cohort

  Participants with autoimmune diseases, including systemic lupus erythematosus, inflammatory myositis, systemic sclerosis, myasthenia gravis, multiple sclerosis, neuromyelitis optica, stiff person syndrome, demyelinating radiculoneuropathy, autoimmune encephalitis, thrombotic thrombocytopenic purpura, or hemolytic anemia, who receive LV009 and are followed prospectively for the safety and clinical effectiveness of LV009.

  Treatment: LV009

• HLA/AAV Sensitization Cohort

  Participants with pre-existing anti-HLA or anti-AAV antibodies who are awaiting organ transplantation or AAV-based gene therapy and receive LV009. Participants are followed prospectively for the safety and clinical effectiveness of LV009, including outcomes related to antibody sensitization.

  Treatment: LV009