Relapsed/Refractory Acute Myeloid LeukemiaPhase 1NCT05518357
LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing LILRB4 STAR-T in people with Relapsed/Refractory Acute Myeloid Leukemia, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
Trial summary
This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in relapsed/refractory acute myeloid leukemia subjects. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Relapsed/Refractory Acute Myeloid Leukemia
- What is being tested?
- LILRB4 STAR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2022to 15 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged 2-70 years, gender is not limited;
- Subjects diagnosed with AML according to WHO 2016 criteria and according to the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2021 Edition)" should meet any of the following relapsed and refractory (R/R) AML patients:
- Patients who have failed two cycles of standard chemotherapy;
- Relapse within 12 months after consolidation and intensification therapy after complete remission (CR);
- Relapse after 12 months but failed to respond to conventional treatment
- two or more recurrences;
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- persistent extramedullary leukemia；
- ECOG physical status level is 0 to 2;
- Bone marrow sample must be LILRB4 positive(Flow Cytometry)
- Major organs must meet the following criteria:
- Liver function: Total bilirubin≤1.5 times the upper limit of normal,ALT and AST≤3 times the upper limit of normal,
- Renal function:Creatinine≤1.5 times the upper limit of normal (ULN) or creatinine clearance rate ≥60ml/min,
- Cardiac function:LVEF≥50%，
- Lung function:Defined as ≤grade 1 dyspnea and blood oxygen saturation >92%;
- Female subjects of reproductive age or male subjects whose partners are women of reproductive age agree to use an effective method of contraception throughout the trial and for 12 months after cell infusion;
- The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- Received CAR-T therapy or other gene-modified cell therapy in the past or participated in other clinical investigators within 1 month before screening;
- Any of the following cardiovascular and cerebrovascular diseases occurred within 6 months before screening:
- congestive heart failure(NYHA stage III),myocardial infarction,unstable angina pectoris,congenital long QT syndrom,Anterior left block,coronary angioplasty,stent implantation,Coronary/peripheral artery bypass grafting,CVA,Transient ischemic attack or pulmonary embolism,Asymptomatic right bundle branch block was allowed;
- Serious arrhythmias requiring treatment (eg, sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes, etc.);
- uncontrolled hypertension (systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg), a history of hypertensive crisis or hypertensive encephalopathy;
- The subject is positive for hepatitis B surface antigen or HBV DNA is higher than the detection limit of analysis method;Positive hepatitis C antibody or HCV RNA is higher than the detection limit of the analytical method;The subjects were positive for syphilis antibody;
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- The subject with known systemic lupus erythematosus, active or uncontrolled autoimmune disease (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (such as HIV infection or serious infectious disease, etc.);
- Previous or concurrent other incurable malignancies with unstable control,Affect the long-term survival of subjects, except for cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or other local prostate cancer after radical treatment, ductal carcinoma in situ after radical resection and at least 5 Years without recurrence of malignant tumor;
- Subjects with current or previous history of central nervous system disease, such as seizures, stroke, severe brain injury, aphasia, paralysis, dementia, Parkinson's disease, mental illness, etc. or central nervous system leukemia (CNSL);
- Subjects with a history of solid organ transplantation or hematopoietic stem cell transplantation (HSCT) within 6 months prior to screening;
- Subjects with aGVHD and cGVHD at screening;
- Subjects who have had any of the following drugs or treatments within the specified time period prior to apheresis:
- Administered any immunosuppressant within 2 weeks prior to apheresis;
- Received any chemotherapy within 2 weeks or 3 half-lives, whichever is shorter, prior to apheresis;
- Received any macromolecule or small molecule targeted therapy such as monoclonal antibody, antibody-drug conjugate (ADC), double antibody, etc. within 4 weeks before apheresis or within 3 half-lives (whichever is shorter);
- Those with mental illness or history of drug abuse;
- Pregnant or breastfeeding subjects;
- The investigator believes that there are other factors that are not suitable for inclusion or that affect subjects participating in or completing the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in relapsed/refractory acute myeloid leukemia subjects.
Read the detailed description
This study will recruit LILRB4 positive AML subjects,and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of LILRB4 STAR-T cells. LILRB4 STAR-T cells will be intravenously infused with a escalated dose of 1E6、3E6、1E7 cells/kg.The purpose of current study is to evaluate the clinical safety and tolerability of LILRB4 STAR-T cells therapy in patients with refractory and relapsed AML.Safety and efficacy of LILRB4 STAR-T cells therapy will be monitored.The primary endpoint of the study is to observe DLT, AE, SAE, CRS and ICANS. Secondary objectives are to observe the efficacy of LILRB4 STAR-T cells, including RFS, EFS and OS, and PK.
- Being tested
- LILRB4 STAR-T
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LILRB4 STAR-TBiological
Subjects with relapsed/refractory acute myeloid leukemia will be enrolled in the study, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of STAR-T cells. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg。
| Study group | Role | What they receive |
|---|---|---|
| LILRB4 STAR-T | Experimental | LILRB4 STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 25-30mg/m2/day and cyclophosphamide treatment at dose 250-300mg/m2 for 3 days and take a rest for 2 days before infusion. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg Receives: Biological: LILRB4 STAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety and tolerability
Subjects are observed for dose-limiting toxicity(DLT) after LILRB4 STAR-T cells infusion, with the recording of adverse events(AE) and serious adverse events(SAE), with a focus on cytokine release syndrome(CRS) and immune cell-associated neurotoxicity(ICANS).All of the AE ratings were assessed according to the CTCAE.
Measured: 12 months
Secondary outcomes (1)
Antitumor efficacy
After infusion of LILRB4 STAR-T cells, the subjects underwent bone marrow puncture every month to evaluate the tumor load in the bone marrow. The efficacy evaluation included complete morphological remission, complete remission with incomplete recovery of blood cytology, and partial remission.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start24 Jun 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Yanda Ludaopei Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, MD/PHD, Principal investigator, HeiBei YanDa Ludaopei hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518357
- Sponsor's protocol ID
- YTS104-001
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 12 Jan 2023
- Results posted
- 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study on the Safety and Efficacy of LILRB4 STAR-T Cells in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
- ClinicalTrials.gov ID
- NCT05518357
- Acronym / sponsor ID
- YTS104-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hebei Yanda Ludaopei HospitalUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 26 Aug 2022 (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 is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of LILRB4 STAR-T cells in relapsed/refractory acute myeloid leukemia subjects.
Detailed description
This study will recruit LILRB4 positive AML subjects,and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of LILRB4 STAR-T cells. LILRB4 STAR-T cells will be intravenously infused with a escalated dose of 1E6、3E6、1E7 cells/kg.The purpose of current study is to evaluate the clinical safety and tolerability of LILRB4 STAR-T cells therapy in patients with refractory and relapsed AML.Safety and efficacy of LILRB4 STAR-T cells therapy will be monitored.The primary endpoint of the study is to observe DLT, AE, SAE, CRS and ICANS. Secondary objectives are to observe the efficacy of LILRB4 STAR-T cells, including RFS, EFS and OS, and PK.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LILRB4 STAR-T | Experimental | Biological: LILRB4 STAR-TLILRB4 STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 25-30mg/m2/day and cyclophosphamide treatment at dose 250-300mg/m2 for 3 days and take a rest for 2 days before infusion. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 2-70 years, gender is not limited;
- Subjects diagnosed with AML according to WHO 2016 criteria and according to the "Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2021 Edition)" should meet any of the following relapsed and refractory (R/R) AML patients:
- ECOG physical status level is 0 to 2;
- Bone marrow sample must be LILRB4 positive(Flow Cytometry)
- Major organs must meet the following criteria:
Key exclusion criteria (18 listed)
- Received CAR-T therapy or other gene-modified cell therapy in the past or participated in other clinical investigators within 1 month before screening;
- Any of the following cardiovascular and cerebrovascular diseases occurred within 6 months before screening:
- The subject is positive for hepatitis B surface antigen or HBV DNA is higher than the detection limit of analysis method;Positive hepatitis C antibody or HCV RNA is higher than the detection limit of the analytical method;The subjects were positive for syphilis antibody;
- The subject with known systemic lupus erythematosus, active or uncontrolled autoimmune disease (such as Crohns disease, rheumatoid arthritis, autoimmune hemolytic anemia, etc.), primary or secondary immunodeficiency (such as HIV infection or serious infectious disease, etc.);
- Previous or concurrent other incurable malignancies with unstable control,Affect the long-term survival of subjects, except for cured cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer or other local prostate cancer after radical treatment, ductal carcinoma in situ after radical resection and at least 5 Years without recurrence of malignant tumor;
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 |
|---|---|---|
| LILRB4 STAR-TSubjects with relapsed/refractory acute myeloid leukemia will be enrolled in the study, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of STAR-T cells. STAR-T cells will be intravenously infused with a escalated dose of 1E6#3E6#1E7 cells/kg。 | Biological | LILRB4 STAR-T |
Primary outcome
Evaluate safety and tolerability
Time frame: 12 months
Subjects are observed for dose-limiting toxicity(DLT) after LILRB4 STAR-T cells infusion, with the recording of adverse events(AE) and serious adverse events(SAE), with a focus on cytokine release syndrome(CRS) and immune cell-associated neurotoxicity(ICANS).All of the AE ratings were assessed according to the CTCAE.
1 secondary outcome
Antitumor efficacy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Peihua Lu, MD/PHD principal investigator
HeiBei YanDa Ludaopei hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LILRB4 STAR-T in people with Relapsed/Refractory Acute Myeloid Leukemia, run by Hebei Yanda Ludaopei Hospital at 1 site in China.
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 16 inclusion and 18 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: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate safety and tolerability (time frame: 12 months). 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 12 Jan 2023.