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Experimental shot at stubborn blood cancers: LV009 injection enters early human trial

NCT ID NCT07330895

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 19 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 100 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.