New shot aims to control Hard-to-Treat blood cancers
NCT ID NCT07284927
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a new treatment called LV009 injection in 10 adults whose blood cancers (certain types of lymphoma or leukemia) have returned or stopped responding to standard therapy. The main goal is to check if the treatment is safe. Participants receive the injection and are monitored for side effects and how their body handles it.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 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: 1. Aged 18 to 70 years (inclusive), irrespective of sex and race. 2. Life expectancy greater than 12 weeks. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2. 4. Meets the National Comprehensive Cancer Network (NCCN) criteria for relapsed or refractory disease, with a confirmed diagnosis of CD19-positive hematolymphoid malignancy 5. Adequate hepatic, renal, and cardiopulmonary function 6. Absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L; Platelet count ≥ 50 × 10⁹/L; CD3-positive T-cell count ≥ 150 cells/μL Exclusion Criteria: 1. Patients who, in the investigator's judgment at screening, require long-term use of immunosuppressive agents. 2. History of cerebrovascular accident or convulsive seizures within 6 months prior to signing the informed consent form. 3. Presence of other active malignant diseases besides the disease under study, with the exception of carcinoma in situ. 4. Patients with severe cardiac disease, unstable systemic diseases, or chronic progressive neurological disorders, etc. 5. Patients who have received CAR-T therapy or other genetically modified cell therapies prior to screening. 6. Patients who have participated in other clinical studies within 1 month prior to screening. 7. Evidence of central nervous system involvement at the time of screening.
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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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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- Patient's own t cells engineered to hunt lymphoma in early trial
- Engineered immune cells aim to wipe out stubborn leukemia
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- The immune cells that could make stem cell transplants work better
- Immunotherapy injection tested against Hard-to-Treat childhood lymphoma