CD19+ Relapse/Refractory B-ALLEarly Phase 1NCT07330895
Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors
A Early Phase 1 study testing Biological: LV009 injection in people with CD19+ Relapse/Refractory B-ALL, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- CD19+ Relapse/Refractory B-ALL
- What is being tested?
- Biological: LV009 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of race.
- Expected survival time exceeds 12 weeks.
- ECOG score 0-2.
- Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.
- Liver, kidney, heart, and lung functions meet the following requirements:
- Creatinine ≤1.5×ULN;
Show all 14Show fewer
- Left ventricular ejection fraction ≥45%;
- Oxygen saturation >91%;
- Total bilirubin ≤1.5×ULN; ALT and AST ≤2.5×ULN.
- Absolute lymphocyte count ≥0.5×10⁹/L; platelet count ≥50×10⁹/L; CD3-positive T cells ≥150/uL.
- 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.
- Subjects must have a body temperature ≤38°C within 24 hours before investigational drug infusion (excluding tumor fever).
- 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.
- 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.
Who cannot join
- Patients judged by investigators to require long-term use of immunosuppressants during screening.
- Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
- Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
- Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
- 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.
- Unstable systemic diseases judged by investigators including but not limited to severe hepatic, renal or metabolic diseases requiring medication.
Show all 10Show fewer
- Patients whose acute toxic effects from prior treatment have not yet resolved.
- Active or uncontrolled infections requiring systemic treatment (excluding mild genitourinary and upper respiratory infections).
- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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 collected from the subjects before and after the infusion for the evaluation of safety, pharmacokinetics, pharmacodynamics, immunogenicity and other indicators.
In addition to the baseline period, during the treatment phase, efficacy assessments will be conducted at 4 weeks, 2 months, 3 months, 6 months after the infusion of the study drug, and then at a frequency of once every 3 months from the 6th to the 24th month. Tumor assessments will be continued until the occurrence of disease progression (PD), initiation of new anti-tumor therapy, death, intolerable toxicity, decision by the investigator or voluntary withdrawal of the subject, whichever comes first.
Read the 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 adverse events related to the study product will be collected. Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) will be graded according to the Lee Criteria (2019), while all other adverse events (AEs) will be graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Dose Escalation: A dose escalation study will be conducted according to the designed dose levels. With the exception of the first dose cohort, where only 1 subject will be enrolled from the perspective of benefit-risk assessment and ethics, all other dose cohorts will adopt the traditional "3+3" dose escalation model. Four fixed dose levels of LV009 Injection will be used for escalation, namely: 0.3×10⁹, 0.6×10⁹, 1.2×10⁹, and 2.4×10⁹ Transduction Units (TU).
Dose Escalation Rules: Only 1 subject will be enrolled at the 0.3×10⁹ TU dose level. If a Dose-Limiting Toxicity (DLT) event occurs during the DLT observation period (28 days after cell infusion), the acceleration phase will be terminated and the "3+3" dose escalation study will be initiated. In the "3+3" dose escalation phase, if no DLTs are observed among 3 evaluable subjects, escalation to the next higher dose cohort is permitted. If 1 DLT occurs among 3 evaluable subjects, an additional 3 evaluable subjects need to be enrolled. If ≥1 further DLT occurs (i.e., the total number of subjects with DLT reaches ≥2), the previous dose level will be defined as the Maximum Tolerated Dose (MTD). A total of 10-19 subjects with CD19-positive hematolymphoid malignancies will be enrolled in the study.
Within each dose cohort, the next subject may be administered the study drug only after the previous subject has completed a minimum of 14 days of safety observation. After the last subject in each dose cohort completes the DLT assessment within 28 days following a single administration, enrollment and treatment for the next dose cohort may commence only after the Safety Review Committee (SRC) reviews and approves the move based on the integration of clinical safety data. If 1 DLT occurs among 3 subjects in a dose cohort, 3 additional subjects need to be enrolled in the same dose cohort (resulting in a total of 6 subjects completing DLT assessment in that cohort):
If no DLTs occur in the 3 additional subjects, dose escalation will continue; If 1 DLT occurs in the 3 additional subjects, dose escalation will be terminated; If >1 DLT occurs in the 3 additional subjects, dose escalation will be terminated, and enrollment of 3 additional subjects at one dose level lower will be required for DLT assessment.
If the investigators, through a comprehensive evaluation of the safety, tolerability, and pharmacokinetic data of subjects in a dose cohort, deem it necessary to expand the sample size of that cohort to further observe its safety and pharmacokinetic profile, the cohort may be expanded to a maximum of 6 subjects after reaching a consensus with the sponsor through consultation.
- Conditions
- CD19+ Relapse/Refractory B-ALL
- Being tested
- Biological: LV009 injection
- Keywords
- relapse/refractory B-ALL
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological: LV009 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| On the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma | Experimental | Single dose, single arm trial, exploring the initial 28 day safety and eicacy of the investigational drug. Receives: Drug: Biological: LV009 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start31 Dec 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD19+ Relapse/Refractory B-ALLStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330895
- Sponsor's protocol ID
- PG-012-10
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of LV009 Injection in the Treatment of Recurrent/Refractory CD19 Positive Blood Tumors
- ClinicalTrials.gov ID
- NCT07330895
- Acronym / sponsor ID
- PG-012-10
- Conditions
- CD19+ Relapse/Refractory B-ALL
- Keywords
- relapse/refractory B-ALL
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 31 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 collected from the subjects before and after the infusion for the evaluation of safety, pharmacokinetics, pharmacodynamics, immunogenicity and other indicators.
In addition to the baseline period, during the treatment phase, efficacy assessments will be conducted at 4 weeks, 2 months, 3 months, 6 months after the infusion of the study drug, and then at a frequency of once every 3 months from the 6th to the 24th month. Tumor assessments will be continued until the occurrence of disease progression (PD), initiation of new anti-tumor therapy, death, intolerable toxicity, decision by the investigator or voluntary withdrawal of the subject, whichever comes first.
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 adverse events related to the study product will be collected. Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) will be graded according to the Lee Criteria (2019), while all other adverse events (AEs) will be graded based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
Dose Escalation: A dose escalation study will be conducted according to the designed dose levels. With the exception of the first dose cohort, where only 1 subject will be enrolled from the perspective of benefit-risk assessment and ethics, all other dose cohorts will adopt the traditional "3+3" dose escalation model. Four fixed dose levels of LV009 Injection will be used for escalation, namely: 0.3×10⁹, 0.6×10⁹, 1.2×10⁹, and 2.4×10⁹ Transduction Units (TU).
Dose Escalation Rules: Only 1 subject will be enrolled at the 0.3×10⁹ TU dose level. If a Dose-Limiting Toxicity (DLT) event occurs during the DLT observation period (28 days after cell infusion), the acceleration phase will be terminated and the "3+3" dose escalation study will be initiated. In the "3+3" dose escalation phase, if no DLTs are observed among 3 evaluable subjects, escalation to the next higher dose cohort is permitted. If 1 DLT occurs among 3 evaluable subjects, an additional 3 evaluable subjects need to be enrolled. If ≥1 further DLT occurs (i.e., the total number of subjects with DLT reaches ≥2), the previous dose level will be defined as the Maximum Tolerated Dose (MTD). A total of 10-19 subjects with CD19-positive hematolymphoid malignancies will be enrolled in the study.
Within each dose cohort, the next subject may be administered the study drug only after the previous subject has completed a minimum of 14 days of safety observation. After the last subject in each dose cohort completes the DLT assessment within 28 days following a single administration, enrollment and treatment for the next dose cohort may commence only after the Safety Review Committee (SRC) reviews and approves the move based on the integration of clinical safety data. If 1 DLT occurs among 3 subjects in a dose cohort, 3 additional subjects need to be enrolled in the same dose cohort (resulting in a total of 6 subjects completing DLT assessment in that cohort):
If no DLTs occur in the 3 additional subjects, dose escalation will continue; If 1 DLT occurs in the 3 additional subjects, dose escalation will be terminated; If >1 DLT occurs in the 3 additional subjects, dose escalation will be terminated, and enrollment of 3 additional subjects at one dose level lower will be required for DLT assessment.
If the investigators, through a comprehensive evaluation of the safety, tolerability, and pharmacokinetic data of subjects in a dose cohort, deem it necessary to expand the sample size of that cohort to further observe its safety and pharmacokinetic profile, the cohort may be expanded to a maximum of 6 subjects after reaching a consensus with the sponsor through consultation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma | Experimental | Drug: Biological: LV009 injectionSingle dose, single arm trial, exploring the initial 28 day safety and eicacy of the investigational drug. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years, regardless of race.
- Expected survival time exceeds 12 weeks.
- ECOG score 0-2.
- Meets the NCCN/CSCO guideline-defined criteria for relapsed/refractory disease and confirmed CD19-positive hematologic malignancy.
- Liver, kidney, heart, and lung functions meet the following requirements:
Key exclusion criteria (10 listed)
- Patients judged by investigators to require long-term use of immunosuppressants during screening.
- Occurrence of cerebrovascular accident or seizure within 3 months prior to signing informed consent.
- Presence of other active malignancies besides the studied disease, excluding carcinoma in situ.
- Peripheral blood hepatitis B virus (HBV) DNA titer exceeding normal reference range.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological: LV009 injectionThe 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. | Drug | On the Safety, Tolerability, and Efficacy of LV009 Injection in the Treatment of Lymphoma |
Primary outcome
Primary Outcome Measure
Time frame: 2 years
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for CD19+ Relapse/Refractory B-ALL
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 1
A Phase I Dose Finding Study of MB-CART2219.1
Lymphoma, CLL
Not yet recruitingPhase 1
4SCAR19U T Cells Targeting B Cell Malignancies
B Cell Malignancies
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Biological: LV009 injection in people with CD19+ Relapse/Refractory B-ALL, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lei Fan, MD (13813976136, fanlei@jsph.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.