Experimental shot at stubborn blood cancers: LV009 injection enters early human trial
NCT ID NCT07330895
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial will test the safety of an experimental cell therapy called LV009 injection in 19 adults with relapsed or refractory CD19-positive blood cancers. Participants receive a single infusion, then are monitored for side effects and tumor response for up to 24 months. The study is not yet recruiting and is too small to prove effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LV009 injection (a type of cell therapy targeting CD19-positive blood cancer cells)
- What this could lead to
- If it works, this could point toward a new treatment option for people with hard-to-treat blood cancers that have come back or not responded to standard therapy.
- What could go wrong
- This is a very early, small study (19 people) focused on safety, not effectiveness. The treatment may cause serious side effects, and it is unknown if it will work at all.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 19 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.