An Evaluation of LY007 Cell Injection for r/r B-NHL (NCT06364852) | Clinical Trial Compass
RecruitingPhase 1
An Evaluation of LY007 Cell Injection for r/r B-NHL
China18 participantsStarted 2021-12-25
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Fully treated cervical carcinoma in situ and a history of other malignant tumors within 5 years prior to screening Adeno-papillary carcinoma, basal cell or squamous cell skin cancer, local front line after radical surgery Except adenocarcinoma and ductal carcinoma in situ after radical surgery;
✕. Hepatitis B surface antigen (HBsAg) positive, or Hepatitis B core antibody (HBcAb) positive and peripheral The blood HBV DNA titer was higher than the lower limit. Hepatitis C virus (HCV) antibody positive and HCV RNA titer was higher than the lower limit of detection. Positive for human immunodeficiency virus (HIV) antibodies; Serological test positive for syphilis;
✕. Any of the following unstable diseases (including but not limited to) have occurred in the 6 months prior to screening Stable angina pectoris; Cerebral ischemia or cerebral vascular accident; Myocardial infarction; Congestive heart failure (New York Heart Association \[NYHA\] classification ≥III); Severe cardiac arrhythmia requiring medical treatment Often; After heart angioplasty or coronary stent implantation or heart bypass surgery; mining History of deep vein thrombosis or pulmonary embolism within 6 months prior to cell collection;
✕. Lymphoma involving the central nervous system (CNS) only (subjects with secondary CNS lymphoma) Allow to be included);
✕. Previous or clinically significant central nervous system history or disease at the time of screening, such as epilepsy, epilepsy Seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, Organic syndrome or mental illness;
✕. Active autoimmune disease (including but not limited to systemic lupus erythematosus, dry disease) within 2 years Dryness syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, Hashimoto Thyroiditis, etc., except for hypothyroidism that can only be controlled by hormone replacement therapy);
✕. Active or uncontrolled infection requiring systemic treatment within 14 days prior to apheresis;
What they're measuring
1
Maximum tolerated dose or clinically recommended dose;
Timeframe: Day0 to 2year
2
Dose limiting toxicity
Timeframe: Day0 to D28
3
Adverse Events , Serious Adverse Events , Adverse Events of Particular Concern, Including cytokine release syndrome , neurotoxicity,physical examination, vital signs, ECOG score, ECG, laboratory testing, etc.