B-NHL, B-ALL
Conditions
Interventions
Single-arm experiment:This study is a single-center, single-arm, investigator-initiated clinical trial targeting patients with relapsed or refractory B-cell lymphoma/leukemia. The investigational drug
Sponsors
No. 960 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects voluntarily sign the informed consent form, are willing and able to comply with all trial requirements. 2.Aged 18-75 years, regardless of gender. 3.Meets the clinical criteria for confirmed CD19-positive relapsed or refractory B-cell lymphoma: a.Diagnosed by histopathology including: Indolent Non-Hodgkin Lymphoma (iNHL) comprising Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL); Aggressive B-cell lymphoma comprising Diffuse Large B-cell Lymphoma (DLBCL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), Transformed Follicular Lymphoma (TFL), and T-cell/Histiocyte-rich Large B-cell Lymphoma (TCRBCL), etc. b.Primary refractory to standard treatment regimens, or c.Progressive Disease (PD) after receiving at least two lines of standard treatment according to guidelines, or Stable Disease (SD) as the best response to the last line of therapy lasting =5% blasts, or b.Early relapse (=12 months) after initial CR, or b.No response to the last line of salvage therapy in patients post-HSCT, or c.Philadelphia chromosome-positive (Ph+) ALL patients who have not achieved CR or have relapsed after treatment with at least two Tyrosine Kinase Inhibitors (TKIs) (or who have documented TKI-resistant mutations such as T315I/A, V299L, F317L/V/I/C, G250E, Y253H, E255K/V, F359V/C/I, etc. – requirement for >=2 TKIs is waived in these cases), or who are intolerant to or contraindicated for TKI therapy. 5.No hematopoietic stem cell transplantation within 6 months prior to enrollment. 6.For Relapsed/Refractory B-cell Lymphoma: At least one measurable lesion according to Lugano 2014 criteria (lymph node lesion >15mm in longest diameter or extranodal lesion >10mm in longest diameter on CT scan, with positive FDG-PET). For Relapsed/Refractory B-ALL: Evidence of evaluable disease (bone marrow aspirate showing >=5% blasts). 7.Expected survival >=12 weeks. 8.Baseline Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 9.Adequate organ function (standards for liver and kidney function may be appropriately adjusted): Alanine aminotransferase (ALT) =60 mL/min Room air oxygen saturation >=92% Left Ventricular Ejection Fraction (LVEF) >=55%, confirmed by echocardiogram with no pericardial effusion and no clinically significant ECG findings Absence of clinically significant pleural effusion 10.
Exclusion criteria
Exclusion criteria: 1.Subjects with active malignant cells in cerebrospinal fluid or brain metastases, or subjects with active central nervous system (CNS) lymphoma or CNS leukemia; 2.Subjects with a history of active CNS disorders, such as seizures, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 3.Subjects who have received other investigational drugs within 30 days prior to screening; 4.Subjects who have previously received any anti-CD19/anti-CD3 therapy or any other anti-CD19 therapy (except those with normal T-cell count and function and CD19-positive tumors); 5.Subjects who have previously received any gene therapy products, including CAR-T therapy (except those without detectable CAR-T cells in vivo, with normal T-cell count and function, and CD19-positive tumors); 6.Subjects who have undergone radiotherapy within 2 weeks prior to infusion; 7.Subjects with active hepatitis B (defined as HBV DNA > 500 IU/mL) or hepatitis C (HCV RNA positive); subjects who are HIV-positive or Treponema pallidum-positive; 8.Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood culture = 5 years. 11.Subjects with arrhythmias uncontrolled by medical management; 12.Subjects receiving oral anticoagulant therapy within 1 week prior to JY231 injection infusion; 13.Subjects with active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis); 14.Women who are pregnant or breastfeeding; female subjects planning pregnancy within 2 years after cell infusion, or male subjects whose partners plan pregnancy within 2 years after their cell infusion; 15.Subjects for whom any study procedure is contraindicated according to the investigator's judgment and/or clinical standards, or who have other medical conditions that may pose an unacceptable risk; 16.Other conditions deemed by the investigator as grounds for exclusion from this clinical trial, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events) ;Maximum Tolerated Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Countries
China
Contacts
Public ContactFang Zhou
No. 960 Hospital of the Joint Logistics Support Force of the People's Liberation Army of China
Outcome results
None listed