NCT07873476Not yet recruiting
Real-world Clinical Effectiveness & Safety LV009, an in Vivo CAR-T for the Treatment of Hematologic Cancers, Auto-immune Diseases & HLA/ AAV Sensitization.
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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 No subjects will be withdrawn from the study, and subjects could freely drop out from the study anytime, simply by not showing up.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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Dec 2031
- Lead sponsor
- Healthy Malaysia Association
- Diseases
- Childhood cancers
- NCT number
- NCT07873476
What you commit to
- Study type: Observational
- Planned participants: 100
- From Oct 2026 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hepatitis B or C or HIV infection.
- Active infection or fever ≥38°C within 3 days of the first scheduled dose of LV009.
Other
- Known active central nervous system (CNS) metastases.
Who the study is looking for
- Willing and able to give written informed consent for participation in the study.
- Diagnosis confirmed by imaging, histology, or biomarkers of one of the following:
- 2.1. Refractory or relapsed hematologic cancers, including acute lymphoblastic leukemia, B-cell lymphomas, or multiple myeloma; 2.2. Autoimmune diseases, including systemic lupus erythematosus (SLE), inflammatory myositis, systemic sclerosis, myasthenia gravis, multiple sclerosis, neuromyelitis optica, stiff person syndrome, demyelinating radiculoneuropathy, autoimmune encephalitis, thrombocytopenic purpura, or hemolytic anemia; or 2.3. Pre-existing anti-HLA or anti-AAV antibodies while on the wait list for organ transplantation or AAV-based gene therapy.
- Adequate marrow, renal, and hepatic function.
- Patients of reproductive potential (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) at the time of pregnancy testing (women of childbearing potential only), during the course of the study, and for 90 days after the last dose of study drug, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 90 days after the last dose of study drug.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tzu Chi Hospital - Jakarta, DKI Jakarta, Indonesia 14470. Coordinator of this site? Confirm its status | Jakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.