B-cell MalignanciesNCT07065279
JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies
A study testing JY231 Injection in people with B-cell Malignancies, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 Malignancies. 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 2 to 75 years
- Conditions the study is for
- B-cell Malignancies
- 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
- 36 participants
- Where
- 1 siteChina
- Study dates
- Jul 2025to 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 2 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
- Histologically confirmed as B-cell Malignancies ;
- Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);
- According to the researcher's assessment, the expected survival period is greater than 3 months;
- Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
- The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin # 34 μ Mol/L; Creatinine clearance rate>30 mL/min; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation(SpO2) ≥ 92%;
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- Peripheral blood lymphocyte absolute count: absolute lymphocyte count(ALC) ≥ 0.5 × 109/L, blood platelet(PLT)>30 × 109/L, Hb>80 g/L, with a single venous access and no other contraindications for blood cell separation;
- Individuals with fertility must agree to the use of efficient contraceptive methods;
- The subject or their legal guardian can understand and voluntarily sign a written informed consent form.
Who cannot join
- Pregnant or lactating women, as well as women with pregnancy plans within six months;
- Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
- Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
- Previously received treatment targeting CD19;
- Received autologous hematopoietic stem cell transplantation within 6 weeks;
- The presence of uncontrollable active bacterial or fungal infections;
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- Allergies to research related drugs or cellular components;
- Active autoimmune diseases exist;
- Patients with unstable or active ulcers or gastrointestinal bleeding currently present;
- Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
- Received other experimental drug treatments within the past 3 months;
- Existence of grade II-IV acute graft versus-host disease(GVHD) or widespread chronic GVHD;
- Researchers believe that other reasons are not suitable for clinical trial participants.
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, 1 recruiting
- Recruiting
920th HJointLogistics
Kunming, Yunnan
Sanbin Wang, PhD,MD, +8613187424131, sanbin1011@163.com
About this study
Official title: JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B-cell Malignancies.
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 Malignancies.
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 Malignancies. 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 2 years to determine if the disease is under control.
- Conditions
- B-cell Malignancies
- Being tested
- JY231 Injection
- Keywords
- B cell tumor, CAR-T, in vivo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JY231 InjectionDrug
Also called in vivo CAR-T
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 2 years.
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of r/r B-cell Malignancies Early exploratory clinicaltrial | Experimental | A single-center, open, single arm study JY231 Injection for the treatment of relapsed or refractory B-cell Malignancies 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.
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
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
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 posted15 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignanciesStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065279
- Sponsor's protocol ID
- JY-CT-25-008
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 15 Jul 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy
- ClinicalTrials.gov ID
- NCT07065279
- Acronym / sponsor ID
- JY-CT-25-008
- Conditions
- B-cell Malignancies
- Keywords
- B cell tumor, CAR-T, in vivo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of ChinaUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 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 Malignancies.
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 Malignancies.
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 Malignancies. 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 2 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 |
|---|---|---|
| JY231 injection for the treatment of r/r B-cell Malignancies Early exploratory clinicaltrial | Experimental | Drug: JY231 InjectionA single-center, open, single arm study JY231 Injection for the treatment of relapsed or refractory B-cell Malignancies 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
- 2 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- up to 75 years (Child, Adult) , either sex, sign informed consent (ICE);
- Histologically confirmed as B-cell Malignancies ;
- Flow cytometry or histology confirmed positive expression of cluster of differentiation 19(CD19);
- According to the researcher's assessment, the expected survival period is greater than 3 months;
- Eastern Cooperative Oncology Group(ECOG) physical condition score ≤ 3;
Key exclusion criteria (13 listed)
- Pregnant or lactating women, as well as women with pregnancy plans within six months;
- Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;
- Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);
- Previously received treatment targeting CD19;
- Received autologous hematopoietic stem cell transplantation within 6 weeks;
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 InjectionAlso: in vivo CAR-TPatients 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 2 years. | Drug | JY231 injection for the treatment of r/r B-cell Malignancies Early exploratory clinicaltrial |
Primary outcome
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.
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.
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 15 Jul 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-cell Malignancies, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 15 Jul 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 Sanbin Wang, PhD (+86 13187424131, sanbin1011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Tolerated Dose(MTD) (time frame: Up to 28 days after infusion). 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 15 Jul 2025.