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JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia | Clinical Trials | Clareo Health

RECRUITINGNA

JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

An Early-Phase Exploratory Clinical Study of JY231 Injection in Relapsed/Refractory B-Cell Lymphoma/Leukemia: Safety, Tolerability, and Preliminary Efficacy

NCT06890065•Shenzhen Genocury Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

This open-label, single-arm study is designed to evaluate the efficacy and safety of in vivo CAR-T cell therapy in patients with relapsed/refractory B cell lymphoma/leukaemia. Upon enrolment, leukapheresis will be performed and patients will receive 3-5 days of fludarabine and cyclophosphamide lymphodepleting therapy followed by an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be evaluated for safety and efficacy for up to 24 months to determine if the disease is under control.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
•2. Age is 18-75 years old and gender is not limited;
•3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
•4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:
•* 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;
•* Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line / multi-line salvage chemotherapy;
•* Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.
•5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\> 5%;
•6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;
•7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\> 15mm, or extranodal lesion of\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.
+22 more criteria

Exclusion Criteria

•1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
•2. 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;
•3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
•4. 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);
•5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);
•6. Subjects with radiation therapy within 2 weeks prior to the infusion;
•7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\> 500 IU / mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;
•8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);
•9. Subjects with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening;
•10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:
+9 more criteria

Locations (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

March 1, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

May 15, 2025

Enrollment

ESTIMATED participants

Conditions

B Acute Lymphoblastic LeukemiaB-Non Hodgkin Lymphoma

Interventions

JY231 Injection

DRUG

Contacts

Xinfeng Chen, PhD

CONTACT

+86-0371-66295320 Fengxinchen1985@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia

Inclusion Criteria

Exclusion Criteria

Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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