An Evaluation of LY007 Cell Injection for Recurrent/Refractory CD20 Was Positive Tolerability, Safety, and Efficacy of B-cell Non-Hodgkin Lymphoma in Open, Single-arm Stage I Clinical Research

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

An evaluation of LY007 cell injection for recurrent/refractory CD20 was positive Tolerability, safety, and efficacy of B-cell non-Hodgkin lymphoma in open, single-arm Phsea I Clinical research

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Participants must meet all of the following inclusion criteria to be enrolled in the study:

‣ Age 18-70 years old (including 18 years old and 70 years old), regardless of gender;

⁃ Can understand the study and have signed the informed consent;

⁃ Expected survival time \> 3 months;

⁃ The American Eastern Oncology Consortium (ECOG) score was 0-1;

⁃ Cd20-positive B-NHL was confirmed cytologically or histologically according to WHO 2016 criteria These include diffuse large B-cell lymphomas (including histologically transformed forms) and transformed follicular lymphomas (TFL); (For the expression status of CD20, the histological diagnosis of CD20 has been clearly documented in the past Positive subjects (diagnosis within 3 months prior to screening); Subjects without prior records, Pathological specimens provided or collected by our hospital were diagnosed as CD20 positive; Not without a clear record For those who provide or collect specimens, the researchers and sponsors will decide whether to be included according to their medical records);

⁃ For recurrent or refractory B-cell non-Hodgkin lymphoma, subjects must have at least been treated with anthracene Treatment with cyclodrugs and rituximab (or other CD20-targeting drugs), and have already received them At least two cycles of treatment; Refractory is defined as the best response to the most recent treatment regimen as disease progression, or the last treatment The optimal response of the regimen (at least 2 cycles) was stable disease with a duration of less than 6 months.

⁃ Does not meet the criteria for autologous hematopoietic stem cell transplantation (auto-HSCT) or is unwilling to perform autologous transplantation Patients with recurrence or progression after blood stem cell transplantation or autologous hematopoietic stem cell transplantation;

⁃ The venous access required for mononuclear cell collection can be established, and the hemoglobin is ≥70 g/L and neutral Granulocyte ≥ 1.0×109/L, platelet ≥50×109

‣ /L, a single nucleus can be performed by the investigator's judgment Cell collection;

⁃ Evaluable lesions identified according to the 2014 Lugano efficacy evaluation criteria;

‣ Organ functions meet the following requirements:

• The investigator assessed sufficient bone marrow function to receive lymphocyte clearance chemotherapy;

∙ Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance (Cockcroft and Gault) \> 30 mL/min/1.73 m2

• ;

∙ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× ULN (ALT and AST in patients with liver metastasis ≤5×ULN);

∙ Total bilirubin ≤2.0 × ULN (for patients with Gilbert's syndrome or lymphoma invading the liver

• ≤3 × ULN);

∙ Lung function: ≤CTCAE grade 1 dyspnea and oxygen saturation of basic finger pulse in indoor air environment Sum degree ≥92%;

∙ Cardiac function: Normal diastolic function, echocardiography or radiation within 1 month prior to enrollment Sexual nuclide active angiography (MUGA) revealed left ventricular ejection fraction (LVEF) ≥ 50%, no clinically significant pericardial effusion. Exclusion criteria Subjects who meet any of the following criteria will not be enrolled in this study

Locations
Other Locations
China
Ruijin hospital
RECRUITING
Shanghai
Contact Information
Primary
Weili Zhao, MD
zwl_trial@163.com
+862164370045
Backup
Zixun Yan, MD
yanzixun125@163.com
+8613482056727
Time Frame
Start Date: 2021-12-25
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 18
Treatments
Experimental: LY007
The CAR T cell preparation to be evaluated in this study is LY007, developed and produced by Shanghai Longyao Biotechnology Co., LTD Cell injection. LY007 cell injection is a chimeric antigen receptor targeting CD20 genetically modified using lentiviral vectors (CAR) Autologous T cells are CD20 CAR-T independently developed by Shanghai Longyao Biotechnology Co., LTD., in the CAR facility The independent co-stimulatory signal receptor OX40 was introduced to increase the proliferation and killing function of CAR-T cells. Table of CAR gene The frame comprises the following elements: (1) MSCVEF1α fusion promoter; (2) Single-chain antibody CD20 scFv targeting CD20; (3) CD8 junction and transmembrane region; (4) Intracellular region of 4-1BB; (5) CD3ζ intracellular region; (6) P2A self-shearing peptide; (7) Co-stimulated receptor OX40
Related Therapeutic Areas
Sponsors
Collaborators: Shanghai Longyao Biotechnology Inc., Ltd., The First Affiliated Hospital with Nanjing Medical University
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov