Actively Recruiting
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
Led by PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Updated on 2025-12-31
19
Participants Needed
1
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of LV009 injection in adults with relapsed or refractory CD19-positive blood cancers, including non-Hodgkin lymphoma and acute lymphoblastic leukemia. The study is an early phase 1 trial aimed at understanding how this treatment behaves in the body and its potential effects, sponsored by PersonGen BioTherapeutics (Suzhou) Co., Ltd. The trial uses a dose escalation design with four fixed doses of LV009 injection: 0.3 × 10^9, 0.6 × 10^9, 1.2 × 10^9, and 2.4 × 10^9 transducing units. Participants receive a single infusion of LV009, and dose escalation proceeds based on safety observations and dose-limiting toxicity assessments over 28 days. If certain safety criteria are met, the next dose group begins enrollment and treatment. Participants are closely monitored from the start of infusion through three months after for treatment-emergent adverse events. Pharmacokinetic measures such as maximum concentration and area under the curve are assessed within 28 to 90 days after infusion. Safety observations require at least 14 days between dosing subjects, and patients undergo clinical and laboratory evaluations including organ function and immune cell counts. The total participation duration depends on safety and pharmacokinetic monitoring timelines.
CONDITIONS
Brief Title
Clinical Study of LV009 Injection for the Treatment of Relapsed/Refractory CD19-Positive Hematologic and Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years old (inclusive)
- Expected survival time exceeds 12 weeks
- ECOG performance status 0-2
- Diagnosed with relapsed or refractory CD19-positive hematologic malignancies including non-Hodgkin lymphoma and acute lymphoblastic leukemia
- Liver, kidney, and cardiopulmonary functions meet study requirements
- Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL
- Body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to infusion, without significant active infection
- No therapeutic doses of corticosteroids (>5 mg/day prednisone or equivalent) or immunosuppressive agents within 5 days prior to infusion
You will not qualify if you...
- Need for long-term use of immunosuppressive agents during screening
- Cerebrovascular accident or seizure within 6 months prior to consent
- Malignant tumors other than study disease (except carcinoma in situ)
- Positive for Hepatitis B surface antigen, Hepatitis B core antibody with abnormal HBV DNA, Hepatitis C antibody with positive HCV RNA, HIV antibody positive, CMV DNA positive, or Syphilis positive
- Severe cardiac conditions including unstable angina, recent myocardial infarction (within 6 months), congestive heart failure NYHA class ≥ III, severe arrhythmias
- Unstable systemic diseases including severe liver, kidney, or metabolic diseases requiring medication
- Chronic progressive neurological diseases
- Not recovered from acute toxic effects of prior treatment
- Active or uncontrolled infections requiring systemic treatment (mild urogenital or upper respiratory infections may be allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 28 days after infusion
Participants receive a single infusion of LV009 injection at one of four fixed dose levels and are closely monitored for safety and dose-limiting toxicities.
1 infusion visit and weekly visits for up to 4 weeks
Duration - Up to 3 months after infusion
Participants are monitored for adverse events and treatment effects for up to 3 months following the infusion.
Monthly visits for up to 3 months
Trial Site Locations
Total: 1 location
1
PersonGen.Anke Cellular Therapeutice Co., Ltd.
Hefei, Anhui, China, 230088
Actively Recruiting
Research Team
X
Xingbing Wang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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