Recurrent or refractory BCL
Conditions
Interventions
Intervention group:ivgtt with JY231 injection
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects voluntarily sign an informed consent form and are willing and able to comply with all trial requirements; 2) Age 18-75 years old; gender is not limited; 3) Flow cytometric analysis or malignant tumor cells positive for CD19; 4) Meet clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL) with follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma with diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL); transformed follicular lymphoma (TFL); and T-rich large B-cell lymphoma large B-cell lymphoma (TCRBCL); 5) Presence of at least one measurable lesion on imaging (Lugano 2014 criteria), 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 FDG-PET. 6) Expected survival =12 weeks; 7) ECOG (Eastern Cooperative Oncology Group) score of 0-1 at baseline; 8) Adequate organ function (the criteria involving liver and kidney function can be appropriately relaxed): Albuminous aminotransferase (ALT) = 3 times the upper limit of normal (ULN); AST = 3 times the 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%, no pericardial effusion confirmed by echocardiography, and no clinically significant ECG findings; Absence of clinically significant pleural effusion; 9) Adequate bone marrow reserve without transfusion, defined as: Absolute neutrophil count (ANC) > 1.000/mm3; Absolute lymphocyte count (ALC) = 300/mm3; Platelets = 50.000/mm3; Hemoglobin > 8.0 g/dl; 10) Subjects on the following medications will be required to be eligible for the following - Steroids: therapeutic doses of steroids must be discontinued 72 hours prior to JY231 infusion. However, physiologic replacement doses of steroids are permitted. - Immunosuppression: any immunosuppressive medications must be discontinued = 4 weeks prior to enrollment; Antiproliferative therapy other than lymphodepleting chemotherapy within 2 weeks of infusion; Antiproliferative therapy other than lymphodepleting chemotherapy within 2 weeks of infusion; CD20 antibody-related therapy must be discontinued within 4 weeks or 5 half-lives, whichever is longer, prior to infusion. CD20 antibody-related therapy must be discontinued within 4 weeks or 5 half-lives (whichever is longer) before infusion; CNS disease prophylaxis must be discontinued 1 week prior to JY231 infusion (e.g., intrathecal methotrexate). 11) Men of childbearing potential, ensure that sexual partners are effectively contraceptive; women of childbearing potential, use effective contraception and agree to use contraception throughout the study.
Exclusion criteria
Exclusion criteria: 1) Subjects with active cerebrospinal fluid malignant cell or brain metastases, or subjects with active central nervous system (CNS) lymphoma 2) Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement; 3) Subjects who have received any other investigational drug within 30 days prior to screening or are still in the washout period; 4) Patients who have received any prior anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy (with the exception of patients with normal T-cell counts and function and CD19-positive tumors); 5) Patients previously treated with any gene therapy product, including CAR-T therapy (except for patients with no CAR-T in the body, normal T-cell count and function, and CD19-positive tumors); 6) Subjects undergoing radiation therapy within 2 weeks prior to infusion; 7) Subjects with active hepatitis B (defined as hepatitis B virus DNA test value >500 IU/mL) or hepatitis C (HCV RNA positive); HIV-positive or syphilis spirochete-positive subjects; 8) Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures = 72 hours prior to infusion); 9) Subjects with unstable angina and/or myocardial infarction within 6 months prior to screening 10) 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 that has been curatively treated and shows no signs 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. 11) Subjects with arrhythmias not controlled by medical management; 12) Subjects receiving oral anticoagulation therapy within 1 week prior to JY231 injection infusion; 13) Subjects with active neurologic autoimmune or inflammatory conditions (e.g., Guillian-Barre syndrome, amyotrophic lateral sclerosis); 14) 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; 15) 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. 16) Other conditions that, in the opinion of the investigator, preclude participation in this clinical trial, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events;ORR:Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics;pharmacodynamics;complete responses rate;partial response rate;Best Overall Response;Progression-free survival;Time to progress;Duration of response;overall survival; | — |
Countries
China
Contacts
Public ContactYi Zhang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed