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
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
Treatments tested in this trial
- JY231 Injection
Treatment groups
Sponsors and collaborators
He Huang
Lead sponsor
Zhejiang University
Sponsor institution