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JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Lymphoma

ConditionB-Non Hodgkin Lymphoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHe Huang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • JY231 Injection

    Drug

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: A single-center, open, single arm studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of adverse events(AE) after infusion

The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24
2

Maximal Tolerated Dose(MTD)

MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

Time frame
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)

Time frame
Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: