Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPersonGen BioTherapeutics (Suzhou) Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
LV009 Injection
Biological/VaccineEligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: LV009 InjectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety
Adverse Events Occurring During the Treatment Period (TEAEs), Serious Adverse Events (SAEs), Replication-Competent Lentivirus (RCL), and Lentiviral Insertion Site Status (Assessed according to the Common Terminology Criteria for Adverse Events, Version 5.0, NCI CTCAE v5.0)
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov