Status:
RECRUITING
JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
Lead Sponsor:
Shenzhen Genocury Biotech Co., Ltd.
Conditions:
B Acute Lymphoblastic Leukemia
B-Non Hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
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, leukaphe...
Eligibility Criteria
Inclusion
- Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
- Age is 18-75 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);
- Grass aminotransferase (AST) ≤3 times 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%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;
- There is no clinically significant pleural effusion;
- Adequate bone marrow reserve without transfusion, defined as:
- Absolute neutrophil count (ANC)\>1.000 / mm3;
- Absolute lymphocyte count (ALC)≥ 300 / mm3;
- Platelet≥50.000/mm3;
- Hemoglobin\>8.0 g/dl;
- Subjects using the following drugs need to meet the following conditions:
- Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;
- Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;
- Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;
- Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;
- CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).
- Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.
Exclusion
- 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;
- Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);
- Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;
- Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and / or clinical criteria.
- 16）Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06890065
Start Date
March 1 2025
End Date
December 1 2027
Last Update
May 15 2025
Active Locations (1)
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1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China