An observational study in HLA/AAV Sensitization, Auto-immune Diseases and Hematologic Cancers, sponsored by Healthy Malaysia Association. Not yet recruiting at 1 site in Indonesia. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Healthy Malaysia Association · Observational
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 No subjects will be withdrawn from the study, and subjects could freely drop out from the study anytime, simply by not showing up.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 specific objectives are: • To determine clinical effectiveness of LV009, an in vivo CAR-T therapy, for the abovementioned indications. • To describe the safety profile of LV009 as evaluated by adverse events reporting and laboratory tests. The study population consists of male or female patients with hematologic cancers, autoimmune diseases, or HLA/AAV sensitization who have exhausted all current standard of care (SOC) therapies and who will consent to receive LV009 therapy.
This is the only study on the registry with Healthy Malaysia Association as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants with refractory or relapsed hematologic cancers, autoimmune diseases, or HLA/AAV sensitization who receive LV009 as part of routine clinical care will be included. The study will evaluate the real-world clinical effectiveness and safety of LV009 in these patient populations.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis confirmed by imaging, histology, or biomarkers of one of the following:
2.1. or relapsed hematologic cancers, including acute lymphoblastic leukemia, B-cell lymphomas, or multiple myeloma; 2.2. 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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Genetic: LV009
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.
Genetic: LV009
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.
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
Incidence and Severity of Post-Treatment Adverse Events
Safety will be evaluated by the incidence, severity, seriousness, and relationship to LV009 of adverse events occurring after LV009 administration. Adverse events will be assessed through clinical evaluation, laboratory tests, and other relevant clinical investigations. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Overall Survival (OS) in Participants With Hematologic Cancers
Overall survival is defined as the time from the date of LV009 administration to death from any cause among participants with hematologic cancers. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Progression-Free Survival (PFS) in Participants With Hematologic Cancers
Progression-free survival is defined as the time from the date of LV009 administration to the first documented disease progression or death from any cause, whichever occurs first, among participants with hematologic cancers. Disease progression will be assessed using the disease-specific response and progression criteria specified in the study protocol. For acute lymphoblastic leukemia (ALL), progression will be assessed based on worsening bone marrow or peripheral blood disease, including an increase in blast burden. For B-cell lymphomas, progression will be assessed based on the appearance of new lesions or an increase in previously involved lesions according to clinical and imaging assessments. For multiple myeloma, progression will be assessed based on disease-specific changes in monoclonal protein, free light chains, plasmacytomas, or other clinical manifestations of disease. Participants who have not experienced disease progression or death will be censored at the date of their
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Event-Free Survival (EFS) in Participants With Hematologic Cancers
Event-free survival is defined as the time from the date of LV009 administration to the first occurrence of treatment failure, disease progression, disease relapse, or death from any cause, whichever occurs first, among participants with hematologic cancers. Treatment failure, disease progression, and relapse will be assessed using the disease-specific response and progression criteria specified in the study protocol. Participants who have not experienced an event at the time of analysis will be censored at the date of their last disease assessment or last known survival status, as applicable.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Disease-Free Survival (DFS) in Participants With Hematologic Cancers
Disease-free survival is defined as the time from the date of LV009 administration to the first documented disease relapse or death from disease or treatment-related toxicity, whichever occurs first, among participants with hematologic cancers who achieve a disease-free state following LV009 administration. Disease relapse will be assessed using the disease-specific response and progression criteria specified in the study protocol. Participants who remain disease-free at the time of analysis will be censored at the date of their last disease assessment.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Treatment Response in Hematologic Cancers
Treatment response to LV009 will be assessed in participants with refractory or relapsed hematologic cancers using disease-specific response criteria specified in the study protocol. For acute lymphoblastic leukemia (ALL), treatment response will be categorized as complete response (CR), complete response with incomplete count recovery (CRi), complete molecular response (CMR), stable disease (SD), or progressive disease (PD), based on bone marrow blast percentage, peripheral blood findings, blood count recovery, and measurable residual disease (MRD), as applicable. For B-cell lymphomas, treatment response will be categorized as complete response (CR), partial response (PR), stable disease (SD), or progressive disease/relapse, based on clinical and imaging assessment of disease involvement. Complete response requires disappearance of evidence of disease, while partial response requires regression of measurable disease without new sites of disease.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Treatment Response in Participants With Autoimmune Diseases
Treatment response will be assessed in participants with autoimmune diseases using commonly used response criteria specified in the study protocol. Response assessments include Definition of Remission in SLE (DORIS) and Lupus Low Disease Activity State (LLDAS) for systemic lupus erythematosus; International Myositis Assessment and Clinical Studies Group (IMACS) Core Set Measures for inflammatory myositis; Scleroderma Clinical Trials Consortium Activity Index (SCTC-AI) for systemic sclerosis; Quantitative Myasthenia Gravis (QMG) score for myasthenia gravis; No Evidence of Disease Activity (NEDA-3) for multiple sclerosis; annualized relapse rate (ARR) for neuromyelitis optica; International Working Group (IWG) response criteria for immune thrombocytopenia; and hemoglobin concentration and transfusion avoidance for immune hemolytic anemia.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Change in Anti-HLA or Anti-AAV Antibody Levels in Sensitized Participants
Change in circulating anti-HLA or anti-AAV antibody levels from baseline will be assessed in participants with pre-existing HLA or AAV sensitization following LV009 administration. Anti-HLA or anti-AAV antibody levels will be measured using the applicable clinically accepted laboratory assay. The antibody response will be characterized by the change in antibody level from baseline and whether the antibody level reaches a clinically acceptable level for the participant's intended organ transplantation or AAV-based gene therapy, as applicable. For participants awaiting organ transplantation, transplantation-related clinical outcomes, including successful engraftment and occurrence of antibody-mediated rejection, may be recorded as clinical follow-up information. For participants awaiting AAV-based gene therapy, successful AAV vector-mediated transgene transduction may be recorded as clinical follow-up information when applicable.
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — The study protocol does not currently specify a definitive plan for sharing individual participant data (IPD) with other researchers. The decision regarding IPD sharing will be determined in accordance with applicable requirements, participant privacy and confidentiality protections, and institutional and regulatory policies.
Start is estimated for Oct 2026; primary completion for Dec 2031, 62 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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