Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors

NCT07330895 | Not Yet Recruiting Early Phase 1

• 1 other identifier: PG-012-10
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

CD19+ Relapse/Refractory B-ALL

Keywords

relapse/refractory B-ALL

Outcome Measures

Primary Outcomes (1)

• Primary Outcome Measure

  Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), RCL, and lentiviral integration site status (according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0, NCI CTCAE v5.0)

  2 years

Study Arms (1)

On the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma

EXPERIMENTAL

Single dose, single arm trial, exploring the initial 28 day safety and eicacy of the investigational drug.

Drug: Biological: LV009 injection

Interventions

Biological: LV009 injection DRUG

The subjects, who sign the informed consent forms and been screeneinclusion/exclusion criteria, will be assigned into0.3×10\^9 TU\~2.4×10\^9 TU cells.

On the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Creatinine ≤1.5×ULN;
• Left ventricular ejection fraction ≥45%;
• Oxygen saturation \>91%;
• Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.
• Absolute lymphocyte count ≥0.5×10⁹/L; platelet count ≥50×10⁹/L; CD3-positive T cells ≥150/uL.
• 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).
• Within 5 days prior to investigational drug infusion, subjects must not receive therapeutic doses of corticosteroids (\>5mg/day prednisone or equivalent) or other immunosuppressive drugs.
• Before investigational drug infusion, subjects must meet the required washout period per Appendix 3 (Drug/Treatment Discontinuation Schedule). (11) Capable of understanding the trial and having signed informed consent.

You may not qualify if:

• Patients judged by investigators to require long-term use of immunosuppressants during screening.
• 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).
• Female subjects of childbearing potential planning pregnancy within 2 years after investigational drug infusion; or male subjects whose partners plan pregnancy within 2 years after infusion.
• Prohibited use of investigational drug when following complications exist: clinical evidence of active infection, fluid overload or congestive heart failure, drug-uncontrolled arrhythmia, hypotension requiring vasopressor support.Other situations deemed unsuitable for enrollment/investigational drug infusion by investigators.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Fan, MD

CONTACT

13813976136; fanlei@jsph.org.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 9, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share