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Clinical Trial NCT07330895 for CD19+ Relapse/Refractory B-ALL is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors Early Phase 1 19 Open-Label Investigator-Initiated

Not yet recruiting
Clinical Trial NCT07330895 is designed to study Treatment for CD19+ Relapse/Refractory B-ALL. This Early Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 31 December 2025 until the study accrues 19 participants. Led by The First Affiliated Hospital with Nanjing Medical University, this study is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 9 January 2026.
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 ...

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Detailed Description
All adverse events will be recorded from the start of study drug infusion in subjects until 3 months after drug infusion, disease progression/relapse, initiation of new anti-disease therapy, or study conclusion, whichever comes first. During the period from 3 months after drug administration, disease progression/relapse, or initiation of new anti-disease therapy (whichever occurs first) to the end of the study, only ...Show More
Official Title

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

Conditions
CD19+ Relapse/Refractory B-ALL
Other Study IDs
  • PG-012-10
NCT ID Number
NCT07330895
Start Date (Actual)
2025-12-31
Last Update Posted
2026-01-09
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
19
Study Type
Interventional
PHASE
Early Phase 1
Status
Not yet recruiting
Keywords
relapse/refractory B-ALL
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalOn the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma
Single dose, single arm trial, exploring the initial 28 day safety and eicacy of the investigational drug.
Biological: LV009 injection
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All

  1. Age ≥18 years, regardless of race.

  2. Expected survival time exceeds 12 weeks.

  3. ECOG score 0-2.

  4. Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.

  5. 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.

  6. Absolute lymphocyte count ≥0.5×10⁹/L; platelet count ≥50×10⁹/L; CD3-positive T cells ≥150/uL.

  7. 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.

  8. Subjects must have a body temperature ≤38°C within 24 hours before investigational drug infusion (excluding tumor fever).

  9. 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.

  10. 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.

  1. Patients judged by investigators to require long-term use of immunosuppressants during screening.
  2. Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
  3. Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
  4. Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
  5. 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.
  6. Unstable systemic diseases judged by investigators including but not limited to severe hepatic, renal or metabolic diseases requiring medication.
  7. Patients whose acute toxic effects from prior treatment have not yet resolved.
  8. Active or uncontrolled infections requiring systemic treatment (excluding mild genitourinary and upper respiratory infections).
  9. 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.
  10. 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.
The First Affiliated Hospital with Nanjing Medical University logoThe First Affiliated Hospital with Nanjing Medical University
Study Central Contact
Contact: Lei Fan, MD, 13813976136, [email protected]
No location data.