Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tu… (NCT07330895) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors
19 participantsStarted 2025-12-31
Plain-language summary
This clinical trial is designed as a single-arm, open-label, single-center investigator-initiated early-phase clinical study, whose primary objective is to evaluate the safety of LV009 Injection in the treatment of subjects with relapsed/refractory CD19-positive hematolymphoid malignancies.
Eligible subjects who have signed the informed consent form will receive an infusion of LV009 Injection. Blood samples will be collected from the subjects before and after the infusion for the evaluation of safety, pharmacokinetics, pharmacodynamics, immunogenicity and other indicators.
In addition to the baseline period, during the treatment phase, efficacy assessments will be conducted at 4 weeks, 2 months, 3 months, 6 months after the infusion of the study drug, and then at a frequency of once every 3 months from the 6th to the 24th month. Tumor assessments will be continued until the occurrence of disease progression (PD), initiation of new anti-tumor therapy, death, intolerable toxicity, decision by the investigator or voluntary withdrawal of the subject, whichever comes first.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years, regardless of race.
✓. Expected survival time exceeds 12 weeks.
✓. ECOG score 0-2.
✓. Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.
✓. Liver, kidney, heart, and lung functions meet the following requirements:
✓. Prophylactic anti-allergy medications (e.g., promethazine, diphenhydramine) should be administered 15-30 minutes before investigational drug infusion to prevent cryoprotectant (e.g., DMSO)-related infusion reactions.
✓. Subjects must have a body temperature ≤38°C within 24 hours before investigational drug infusion (excluding tumor fever).
Exclusion criteria
✕. Patients judged by investigators to require long-term use of immunosuppressants during screening.
What they're measuring
1
Primary Outcome Measure
Timeframe: 2 years
Trial details
NCT IDNCT07330895
SponsorThe First Affiliated Hospital with Nanjing Medical University
✕. Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
✕. Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
✕. Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
✕. Severe cardiac diseases including but not limited to: unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (NYHA class ≥III), severe arrhythmia.
✕. Unstable systemic diseases judged by investigators including but not limited to severe hepatic, renal or metabolic diseases requiring medication.
✕. Patients whose acute toxic effects from prior treatment have not yet resolved.
✕. Active or uncontrolled infections requiring systemic treatment (excluding mild genitourinary and upper respiratory infections).