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New treatment option for Non-Hodgkin Lymphoma (NHL)
Official title Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
ClinicalTrials.gov ID: NCT07312630
What this study is testing
What is LV009 Injection Infusion?
LV009 Injection Infusion is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non-hodgkin lymphoma (nhl).
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
- Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic 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
- Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions
- Expected survival time exceeds 12 weeks
- ECOG performance status 0-2
- Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including...
- Liver and kidney function, as well as cardiopulmonary function, meet requirements.
You likely can't join if
- Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.
- Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.
- Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer...
- Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior...
- Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver...
See the full eligibility criteria
- Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions
- Expected survival time exceeds 12 weeks
- ECOG performance status 0-2
- Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
- Liver and kidney function, as well as cardiopulmonary function, meet requirements.
- Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL.
- people must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection.
- Within 5 days prior to the study drug infusion, people must not receive therapeutic doses of corticosteroids (\>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents.
- Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded.
- Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded.
- Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion).
- Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive...
- Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association...
- Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication.
- Patients with chronic progressive neurological diseases should be excluded.
- Patients who have not recovered from acute toxic effects following prior treatment must be excluded.
- Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for...
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, 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 Hefei, Anhui, 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.