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Recruiting NCT07284927

Clinical Study of LV009 Injection for the Treatment of Hematologic and Lymphoid Malignancies

Phase I Interventional Non-Hodgkin Lymphoma Acute Lymphoblastic Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LV009 Injection.
Who it may be relevant to
Registry conditions: Non-Hodgkin Lymphoma, Acute Lymphoblastic Leukemia. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological LV009 Injection
    Eligible subjects who pass the screening process after providing signed informed consent will receive an infusion of LV009 Injection.

Primary outcome measures

  • Safety [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • 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
  • Adequate hepatic, renal, and cardiopulmonary function
  • Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL

Exclusion criteria

  • 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.
  • Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening.
  • Patients who have participated in other clinical studies within 1 month prior to screening.
  • Evidence of central nervous system involvement at the time of screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT07284927 · PG-012-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗