HLA/AAV SensitizationLV009NCT07873476
Real-world Clinical Effectiveness & Safety LV009, an in Vivo CAR-T for the Treatment of Hematologic Cancers, Auto-immune Diseases & HLA/ AAV Sensitization.
An observational study of HLA/AAV Sensitization and Auto-immune Diseases, run by Healthy Malaysia Association at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HLA/AAV Sensitization, Auto-immune Diseases, Hematologic Cancers
- What is being tested?
- LV009
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Oct 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- Known active central nervous system (CNS) metastases.
- Known hepatitis B or C or HIV infection.
- Active infection or fever ≥38°C within 3 days of the first scheduled dose of LV009.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Tzu Chi Hospital - Jakarta, DKI Jakarta, Indonesia 14470.
Jakarta, DKI Jakarta, 14470
Clinical Study Coordinator, +60128086859, clinical88study@gmail.com
Edi Setiawan Tehuteru, Sp.A, Subsp.H.O. (K), M.H.A
About this study
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.
Read the detailed description
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.
- Being tested
- LV009
- Keywords
- in vivo CAR-T therapy, hematologic cancers, auto-immune diseases, HLA/AAV sensitization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LV009Genetic
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: 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. Receives: Genetic: 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. Receives: Genetic: LV009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From LV009 administration through 5 years after administration or death, whichever occurs first.
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From LV009 administration through 5 years after administration or death, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HLA/AAV SensitizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthy Malaysia Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teck Onn Lim, Study chair, ClinResearch, GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873476
- Sponsor's protocol ID
- HR 26-05
- Acronym
- LV009
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Effectiveness & Safety LV009, an in Vivo CAR-T for the Treatment of Hematologic Cancers, Auto-immune Diseases & HLA/ AAV Sensitization.
- ClinicalTrials.gov ID
- NCT07873476
- Acronym / sponsor ID
- LV009 / HR 26-05
- Keywords
- in vivo CAR-T therapy, hematologic cancers, auto-immune diseases, HLA/AAV sensitization
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Healthy Malaysia AssociationUniversity, hospital or other
- Study start
- 28 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hematologic Cancer Cohort | – | Genetic: LV009Participants 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. |
| Autoimmune Disease Cohort | – | Genetic: LV009Participants 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. |
| HLA/AAV Sensitization Cohort | – | Genetic: LV009Participants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Known active central nervous system (CNS) metastases.
- Known hepatitis B or C or HIV infection.
- Active infection or fever ≥38°C within 3 days of the first scheduled dose of LV009.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LV009LV009 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 | Genetic | Autoimmune Disease Cohort, HLA/AAV Sensitization Cohort, Hematologic Cancer Cohort |
Primary outcome
Incidence and Severity of Post-Treatment Adverse Events
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
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)
4 secondary outcomes
Overall Survival (OS) in Participants With Hematologic Cancers
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Progression-Free Survival (PFS) in Participants With Hematologic Cancers
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Event-Free Survival (EFS) in Participants With Hematologic Cancers
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Disease-Free Survival (DFS) in Participants With Hematologic Cancers
Time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teck Onn Lim study chair
ClinResearch, GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HLA/AAV Sensitization and Auto-immune Diseases, run by Healthy Malaysia Association at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jau Shya Clinical Study Contact (+60128086859, jaushya@healthymalaysia.org.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Post-Treatment Adverse Events (time frame: From LV009 administration through 5 years after administration or death, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.