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New treatment option for Non-Hodgkin Lymphoma
Official title Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
ClinicalTrials.gov ID: NCT07284927
What this study is testing
What is LV009 Injection?
LV009 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-hodgkin lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial is designed as a single-arm, open-label, single-center, investigator-initiated, early-phase study. Its primary objective is to evaluate the safety of LV009 Injection in subjects with relapsed/refractory CD19-positive hematolymphoid malignancies.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18 to 70 years (inclusive), irrespective of sex and race.
- Life expectancy greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
- Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive...
- Adequate hepatic, renal, and cardiopulmonary function
You likely can't join if
- Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
- History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
- Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
- Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
- Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
- Patients who have participated in other clinical studies within 1 month prior to screening.
See the full eligibility criteria
- Aged 18 to 70 years (inclusive), irrespective of sex and race.
- Life expectancy greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2.
- Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy
- Adequate hepatic, renal, and cardiopulmonary function
- Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL
- Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents.
- History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form.
- Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ.
- Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc.
- Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
- Patients who have participated in other clinical studies within 1 month prior to screening.
- Evidence of central nervous system involvement at the time of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.