JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-75
SponsorAffiliated Hospital of Guangdong Medical University
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 / leukemia. 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 / leukemia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
Age is 12-75 years old and gender is not limited;
Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;
Disqualifiers
Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);
Trial design
Design model
Single group
Treatments tested in this trial
JY231 Injection
DrugThis 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 lymphoma/ 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 2 years to determine if the disease is under control.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup 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 242
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 infusionSecondary 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
Up to 3 months after infusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov