B-ALLNCT06902025
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia
A study testing JY231 Injection in people with B-ALL, run by He Huang at 1 site in China.
Trial summary
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-ALL
- What is being tested?
- JY231 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~75 years old, gender is not limited;
- Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
- Meet the diagnosis of relapsed/refractory (relapsed/refractory) r/r CD19+ B-ALL, including any of the following:
- A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy;
- C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:
- ① Relapse or refractory after treatment with at least two tyrosine kinase inhibitor (TKI) agents or intolerance to TKI-type agents;
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- ② Resistance or failure to achieve remission after receiving second-line TKI therapy;
- ③ Not suitable for TKI therapy;
- Bone marrow cytomorphology with >5% prolymphocytes + juvenile lymphocytes; or flow Minimal Residual Disease(MRD) >=0.01%
- Serum total bilirubin ≤ 51 mol/L, serum alanine aminotransferase (ALT) and azelaic transaminase (AST) both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol/L, and platelets ≥ 20×109/L;
- Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
- Subjects without active pulmonary infection and inspiratory finger pulse oxygen saturation ≥92%;
- Subjects have not received radiotherapy, chemotherapy, monotherapy or other anti-ALL therapy within 1 week prior to screening;
- Predicted survival of 3 months or more;
- Eastern Cooperative Oncology Group(ECOG) score of 0-2;
- Subjects or their legal guardians volunteered to participate in this study and signed an informed consent form;
Who cannot join
- Subjects with active central nervous system (CNS) leukemia;
- Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
- Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;
- Subjects who have had radiation therapy within 2 weeks prior to infusion;
- Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);
- Subjects with unstable angina and/or myocardial infarction within 6 months prior to Screening;
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- Subjects with other prior or concurrent malignancies, with the following exceptions:
- ① Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);
- ② Cancer in situ of the cervix or breast that has been curatively treated and shows no signs of recurrence for at least 3 years prior to study entry;
- ③ primary malignancy that has been completely resected and in complete remission for ≥ 5 years.
- Presence of subjects with arrhythmias not controlled by medical management;
- Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);
- Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;
- Subjects who, in the investigator's judgment and/or clinical criteria, have a contraindication to any of the investigational procedures or have other medical conditions that may place them at unacceptable risk.
- Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
He Huang, PhD, 0571-87236703, hehuangyu@126.com
He Huang, PhD
About this study
Official title: An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).
Read the detailed description
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 15 years to determine if the disease is under control.
- Conditions
- B-ALL
- Being tested
- JY231 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231 InjectionDrug
Patients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 15 years.
| Study group | Role | What they receive |
|---|---|---|
| A single-center, open, single arm study | Experimental | JY231 Injection for the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject. Receives: Drug: JY231 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events(AE) after infusion
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Measured: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
Maximal Tolerated Dose(MTD)
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
Measured: Up to 28 days after infusion
Secondary outcomes (1)
Objective Response Rate
Objective Response Rate(ORR) is defined as the proportion of subjects achieving complete remission(CR) and partial response(PR).
Measured: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start31 Mar 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 B-ALLStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, He Huang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902025
- Sponsor's protocol ID
- JY-CT-24-008
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)
- ClinicalTrials.gov ID
- NCT06902025
- Acronym / sponsor ID
- JY-CT-24-008
- Conditions
- B-ALL
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Study start
- 31 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Mar 2025 (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 study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).
Detailed description
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell(CAR-T cell) therapy in patients with relapsed refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 15 years to determine if the disease is under control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single-center, open, single arm study | Experimental | Drug: JY231 InjectionJY231 Injection for the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) subjects who meet the inclusion criteria will receive a single intravenous injection of JY231, followed by regular observation and follow-up of the subject. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age 18~75 years old, gender is not limited;
- Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
- Meet the diagnosis of relapsed/refractory (relapsed/refractory) r/r CD19+ B-ALL, including any of the following:
- A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy;
- C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:
Key exclusion criteria (15 listed)
- Subjects with active central nervous system (CNS) leukemia;
- Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;
- Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;
- Subjects who have had radiation therapy within 2 weeks prior to infusion;
- Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);
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 |
|---|---|---|
| JY231 InjectionPatients were enrolled and given a single dose of JY231 injection intravenously, hospitalized for observation over the following month, and followed up for observation over the following 15 years. | Drug | A single-center, open, single arm study |
Primary outcome
Incidence of adverse events(AE) after infusion
Time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.
Maximal Tolerated Dose(MTD)
Time frame: Up to 28 days after infusion
MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.
1 secondary outcome
Objective Response Rate
Time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
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 30 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JY231 Injection in people with B-ALL, run by He Huang 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 15 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 30 Mar 2025. 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.
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 He Huang, PhD (0571-87236703, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events(AE) after infusion (time frame: Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24). The study lists 2 primary outcomes in all. 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 30 Mar 2025.