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

NCT06940960 | Recruiting

• 1 other identifier: JY-CT-24-009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

B Acute Lymphoblastic Leukemia; B-Non Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included

  Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

• Maximal Tolerated Dose(MTD)

  MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

Secondary Outcomes (1)

• Objective Response Rate

  Up to 3 months after infusion

Study Arms (1)

A single-center, open, single arm study

EXPERIMENTAL

JY231 Injection for the Treatment of relapsed/refractory B cell lymphoma/ leukemia Subjects who meet the Inclusion Criteria will receive intravenous JY231. JY231 infusion will produce in vivo CAR-T cells in the body.

Drug: JY231 Injection

Interventions

JY231 Injection DRUG

This 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.

A single-center, open, single arm study

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\> 5%;
• No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;
• 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.
• More than 12 weeks of expected survival period
• Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;
• Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):
• Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);

You may not qualify if:

• 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);
• 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);
• Subjects with radiation therapy within 2 weeks prior to the infusion;
• 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;
• Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);
• Subjects with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening;
• Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:
• Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);
• Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;
• The primary malignancy has been completely removed and is in complete remission for 5 years.
• Arrhythmic subjects without medical management control;
• Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (1)

Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jinqi Huang, PhD

  Guangzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinqi Huang, PhD

CONTACT

+86 13533550200; florahjq@163.com

Jinqi Huang

CONTACT

+86-020-81045412; florahjq@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 23, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)