B-ALLNCT06689917
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia
A study testing JY231 Injection in people with B-ALL and B-NHL, run by Tongji Hospital 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 lymphoma / leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2025to 31 Dec 2026
- 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
- Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
- Age is 18-75 years old and gender is not limited;
- Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
- Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:
- Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;
- Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line / multi-line salvage chemotherapy;
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- Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.
- Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was> 5%;
- No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;
- At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of> 15mm, or extranodal lesion of> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.
- More than 12 weeks of expected survival period
- Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;
- Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):
- Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);
- Grass aminotransferase (AST) ≤3 times ULN;
- Total bilirubin ≤1.5 times ULN;
- Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min;
- Indoor oxygen saturation ≥ 92%;
- Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;
- There is no clinically significant pleural effusion;
- Adequate bone marrow reserve without transfusion, defined as:
- Absolute neutrophil count (ANC)>1.000 / mm3;
- Absolute lymphocyte count (ALC)≥ 300 / mm3;
- Platelet≥50.000/mm3;
- Hemoglobin>8.0 g/dl;
- Subjects using the following drugs need to meet the following conditions:
- Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;
- Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;
- Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;
- Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;
- CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).
- Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.
Who cannot join
- Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
- Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
- Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
- Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);
- Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);
- Subjects with radiation therapy within 2 weeks prior to the infusion;
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- Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value> 500 IU / mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;
- Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);
- Subjects with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening;
- Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:
- Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);
- Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;
- The primary malignancy has been completely removed and is in complete remission for 5 years.
- Arrhythmic subjects without medical management control;
- Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;
- Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);
- Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;
- Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and / or clinical criteria.
- Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, 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, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hubei
Jia Wei, PhD, 86-027-83662680, jiawei@tjh.tjmu.edu.cn
About this study
Official title: An Early Exploratory Clinical Study of the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma/Leukaemia
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / 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 lymphoma / leukemia.
Read the detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory B-cell lymphoma/leukaemia. This study incorporates two pretreatment regimens: lymphodepletion and non-lymphodepletion.
In the lymphodepletion regimen:
Upon enrolment, leukapheresis will be performed. Subjects will then undergo 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, followed by concomitant intravenous infusion of the JY231 preparation and autologous peripheral blood mononuclear cell(PBMC) via a double-lumen catheter.
In the non-lymphodepletion regimen:
Patients will receive direct intravenous injection of the JY231 preparation.
Following infusion, subjects will undergo safety and efficacy assessments for up to 3 months. For those achieving sustained remission at 3 months post-infusion, follow-up will be conducted for at least 24 months to evaluate disease control status.
- 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
This study employs two pretreatment regimens:
In the lymphodepletion regimen, upon enrollment, subjects undergo leukapheresis followed by 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, culminating in intravenous infusion of JY231 and autologous patient PBMCs via a double-lumen catheter; in the non-lymphodepletion regimen, subjects receive direct intravenous injection of the JY231 preparation immediately after enrollment.
| Study group | Role | What they receive |
|---|---|---|
| JY231 injection for the treatment of relapsed or refractory B cell lympho Early exploratory clinica | Experimental | JY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia subjects who meet the inclusion criteria will receive intravenous JY231. JY231 infusion will produce CAR-T cells in the body. 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 posted15 Nov 2024
- Study start20 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- More trials run by Tongji HospitalThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Wei, Tongji Hospital
- Investigators
- Jia Wei, Doctor, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689917
- Sponsor's protocol ID
- JY-CT-24-001
- Status last verified
- Jul 2025
- First submitted
- 10 Nov 2024
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Study of the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma/Leukaemia
- ClinicalTrials.gov ID
- NCT06689917
- Acronym / sponsor ID
- JY-CT-24-001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Nov 2024 (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 lymphoma / 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 lymphoma / leukemia.
Detailed description
This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory B-cell lymphoma/leukaemia. This study incorporates two pretreatment regimens: lymphodepletion and non-lymphodepletion.
In the lymphodepletion regimen:
Upon enrolment, leukapheresis will be performed. Subjects will then undergo 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, followed by concomitant intravenous infusion of the JY231 preparation and autologous peripheral blood mononuclear cell(PBMC) via a double-lumen catheter.
In the non-lymphodepletion regimen:
Patients will receive direct intravenous injection of the JY231 preparation.
Following infusion, subjects will undergo safety and efficacy assessments for up to 3 months. For those achieving sustained remission at 3 months post-infusion, follow-up will be conducted for at least 24 months to evaluate disease control status.
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 relapsed or refractory B cell lympho Early exploratory clinica | Experimental | Drug: JY231 InjectionJY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia subjects who meet the inclusion criteria will receive intravenous JY231. JY231 infusion will produce CAR-T cells in the body. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
- Age is 18-75 years old and gender is not limited;
- Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
- Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:
- Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was> 5%;
Key exclusion criteria (19 listed)
- Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
- Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
- Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
- Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);
- Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);
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 InjectionThis study employs two pretreatment regimens: In the lymphodepletion regimen, upon enrollment, subjects undergo leukapheresis followed by 3-5 days of lymphodepleting therapy with fludarabine and cyclophosphamide, culminating in intravenous infusion of JY231 and autologous patient PBMCs via a double-lumen catheter; in the non-lymphodepletion regimen, subjects receive direct intravenous injection of the JY231 preparation immediately after enrollment. | Drug | JY231 injection for the treatment of relapsed or refractory B cell lympho Early exploratory clinica |
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 8 Jul 2025.
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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.
Jia Wei, Doctor principal investigator
Tongji Hospital
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 and B-NHL, run by Tongji 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 32 inclusion and 19 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 8 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 Jia Wei, Doctor (86-027-83662680, jiawei@tjh.tjmu.edu.cn), 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 8 Jul 2025.