NCT07312630 Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 19 participants in total. It began in 2025-09-25 with a primary completion date of 2026-09-25.

Brief Summary

Evaluate the safety, pharmacokinetic (PK) characteristics, and pharmacodynamic (PD) characteristics of LV009 injection in subjects with relapsed/refractory CD19-positive hematologic malignancies.

Eligibility Criteria

Inclusion 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. * Subjects 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, subjects must not receive therapeutic doses of corticosteroids (\>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents. Exclusion Criteria: * 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 with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.) * 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 \[NYHA\] class ≥ III), and severe arrhythmias. * 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 inclusion).

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