New CAR-T therapy takes on tough blood cancers
NCT ID NCT07312630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new cell therapy called LV009 for people with certain blood cancers (lymphoma and leukemia) that have come back or not responded to treatment. The therapy uses a patient's own immune cells, modified to target cancer cells. The main goal is to check safety and how the therapy behaves in the body, with only 19 participants enrolled so far.
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 CAR-T cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for people with certain blood cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early, small trial (19 people) focused on safety and dosing. It may not show strong effectiveness, and there are risks of serious side effects like cytokine release syndrome.
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.
- Started
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Sep 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 70 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: * Age 18 to 70 years old (inclusive of both age limits), no gender restrictions, no racial restrictions * Expected survival time exceeds 12 weeks * ECOG performance status 0-2 * Meets the NCCN guidelines' criteria for recurrence/refractory disease and is diagnosed with CD19-positive hematologic malignancies, including non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL) * Liver and kidney function, as well as cardiopulmonary function, meet requirements. * Absolute lymphocyte count ≥ 0.5 × 10⁹/L; platelet count ≥ 50 × 10⁹/L; CD3-positive T cells ≥ 150 cells/μL. * Subjects must have a body temperature ≤ 38°C (excluding tumor fever) within 24 hours prior to study drug infusion and must not have significant active infection. * Within 5 days prior to the study drug infusion, subjects must not receive therapeutic doses of corticosteroids (\>5 mg/day of prednisone or other equivalent doses of corticosteroids) or other immunosuppressive agents. Exclusion Criteria: * Patients deemed by the investigator to require long-term use of immunosuppressive agents during screening should be excluded. * Patients who have experienced a cerebrovascular accident or seizure within the six months prior to signing the informed consent form must be excluded. * Patients with malignant tumors other than the study disease must be excluded (only patients with carcinoma in situ may be considered for inclusion). * Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer outside normal reference range; Hepatitis C virus (HCV) antibody positive with peripheral blood hepatitis C virus (HCV) RNA positive; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive; Syphilis positive. (Patients meeting any criterion in this section must be excluded.) * Patients with severe cardiac conditions must be excluded, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] class ≥ III), and severe arrhythmias. * Patients judged by the investigator to have unstable systemic diseases must be excluded, including but not limited to those with severe liver, kidney, or metabolic diseases requiring medication. * Patients with chronic progressive neurological diseases should be excluded. * Patients who have not recovered from acute toxic effects following prior treatment must be excluded. * Patients with active infections requiring systemic treatment or uncontrolled infections should be excluded (patients with mild urogenital tract infections and upper respiratory tract infections may be considered for inclusion).
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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PersonGen.Anke Cellular Therapeutice Co., Ltd.
RECRUITINGHefei, Anhui, 230088, China
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- Can a targeted drug hit the mark in Hard-to-Treat blood cancers?