B-Non Hodgkin LymphomaNCT06879470
JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Lymphoma
A study testing JY231 Injection in people with B-Non Hodgkin Lymphoma, 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 lymphoma. 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-Non Hodgkin Lymphoma
- 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
- Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily signed an informed consent form and were willing and able to comply with all study requirements;
- Age 18~75 years old, gender is not limited;
- Malignant tumor cells positive for Cluster of Differentiation 19(CD19);
- Meet the criteria for relapsed or refractory B-cell lymphoma. Relapsed: the subject's tumor reappears after achieving complete remission of the disease; refractory: the subject is ineffective or in only partial remission on standard treatment regimens. Subjects must have relapsed or become refractory after receiving at least two lines of systemic therapy or autologous hematopoietic stem cell transplantation.
- The presence of at least one measurable lesion on imaging of relapsed or refractory B-cell lymphoma, i.e., a lymph node lesion >15 mm in length or an extranodal lesion >10 mm in length based on CT cross-sectional images, along with a positive Fluorodeoxyglucose Computed Tomography(FDG-PET).
- Expected survival ≥12 weeks;
Show all 15Show fewer
- Eastern Cooperative Oncology Group(ECOG) score of 0 to 1 at baseline;
- Good organ function (the standard can be appropriately relaxed for indicators involving liver and kidney function)
- Albuminous aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN);
- Albumin transaminase (AST) ≤ 3 times the ULN;
- Total bilirubin ≤ 1.5 times the ULN;
- Serum creatinine ≤1.5 times ULN or creatinine clearance ≥30 mL/min;
- Room oxygen saturation ≥92% without oxygen;
- left ventricular ejection fraction (LVEF) ≥50%;
- Men of childbearing potential to ensure effective contraception for sexual partners; women of childbearing potential to use effective contraception and agree to use contraception throughout the study period.
Who cannot join
- Subjects with active central nervous system (CNS) lymphoma;
- 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;
Show all 15Show fewer
- Subjects with other prior or concurrent malignancies, with the following exceptions:
- Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);
- Carcinoma in situ of the cervix or breast, curatively treated, with no sign of recurrence for at least 3 years prior to study entry;
- Primary malignant tumor 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 study 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 Lymphoma
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. 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.
Read the detailed description
This study included the screening period (Day -18 to Day -7), the baseline period (Day -1), the treatment and observation period (Day 0 to 28), and the follow-up period (Month 2[from Day 29] to Year 15). Participants eligible for the screening period will be admitted to the study center for a single JY231 treatment and a follow-up period after the end of the treatment and observation period.
After completing the follow-up for the first five years, methods such as telephone or written questionnaires can be used, and relevant samples should be collected as much as possible. The subjects should be followed up at least once a year until the end of the follow-up period. The maximum monitoring time can be extended to 15 years, and all monitoring data during the extension process need to be recorded.
- Conditions
- B-Non Hodgkin Lymphoma
- 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 is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with relapsed refractory B-cell leukemia.
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 group | Role | What they receive |
|---|---|---|
| A single-center, open, single arm study | Experimental | JY231 Injection for the treatment of relapsed or refractory B-cell lymphoma 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 posted17 Mar 2025
- Study startMar 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-Non Hodgkin LymphomaStudies 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
- NCT06879470
- Sponsor's protocol ID
- JY-CT-24-006
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 17 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 17 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 Lymphoma
- ClinicalTrials.gov ID
- NCT06879470
- Acronym / sponsor ID
- JY-CT-24-006
- Conditions
- B-Non Hodgkin Lymphoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- He HuangUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 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 lymphoma. 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.
Detailed description
This study included the screening period (Day -18 to Day -7), the baseline period (Day -1), the treatment and observation period (Day 0 to 28), and the follow-up period (Month 2[from Day 29] to Year 15). Participants eligible for the screening period will be admitted to the study center for a single JY231 treatment and a follow-up period after the end of the treatment and observation period.
After completing the follow-up for the first five years, methods such as telephone or written questionnaires can be used, and relevant samples should be collected as much as possible. The subjects should be followed up at least once a year until the end of the follow-up period. The maximum monitoring time can be extended to 15 years, and all monitoring data during the extension process need to be recorded.
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 lymphoma 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 (15 listed)
- Subjects voluntarily signed an informed consent form and were willing and able to comply with all study requirements;
- Age 18~75 years old, gender is not limited;
- Malignant tumor cells positive for Cluster of Differentiation 19(CD19);
- Meet the criteria for relapsed or refractory B-cell lymphoma. Relapsed: the subject's tumor reappears after achieving complete remission of the disease; refractory: the subject is ineffective or in only partial remission on standard treatment regimens. Subjects must have relapsed or become refractory after receiving at least two lines of systemic therapy or autologous hematopoietic stem cell transplantation.
- The presence of at least one measurable lesion on imaging of relapsed or refractory B-cell lymphoma, i.e., a lymph node lesion >15 mm in length or an extranodal lesion >10 mm in length based on CT cross-sectional images, along with a positive Fluorodeoxyglucose Computed Tomography(FDG-PET).
Key exclusion criteria (15 listed)
- Subjects with active central nervous system (CNS) lymphoma;
- 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 InjectionThis is an open-label, single-arm study to evaluate the efficacy and safety of in vivo Chimeric Antigen Receptor T-Cell (CAR-T) therapy in patients with relapsed refractory B-cell leukemia. 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. | 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 17 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for B-Non Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
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
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
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-Non Hodgkin Lymphoma, 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 15 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 17 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 17 Mar 2025.