JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia - A Safety, Tolerability, and Efficacy Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhenzhou
Contact Information
Primary
Xinfeng Chen, Doctor
Fengxinchen1985@163.com
15837167101
Time Frame
Start Date: 2023-09-07
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: JY231 Injection for the Treatment of relapsed or 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.
Sponsors
Leads: Shenzhen Genocury Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov