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

NCT07312630 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2025-12-31

No results posted yet for this study

Summary

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

Conditions

  • Non-Hodgkin Lymphoma (NHL)
  • Acute Lymphoblastic Leukemia (ALL), Adult

Interventions

BIOLOGICAL

LV009 Injection Infusion

A dose escalation was conducted using four fixed doses of LV009 injection solution: 0.3 × 10\^9, 0.6 × 10\^9, 1.2 × 10\^9, and 2.4 × 10\^9 TU.

Sponsors & Collaborators

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2026-09-25
Completion
2027-12-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07312630 on ClinicalTrials.gov