Actively Recruiting
An Evaluation of LY007 Cell Injection for r/r B-NHL
Led by Ruijin Hospital · Updated on 2024-04-15
18
Participants Needed
1
Research Sites
231 weeks
Total Duration
On this page
Sponsors
R
Ruijin Hospital
Lead Sponsor
T
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
An Evaluation of LY007 Cell Injection for r/r B-NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- Able to understand the study and give informed consent
- Expected to live more than 3 months
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Confirmed CD20-positive B-cell non-Hodgkin lymphoma as per WHO 2016 criteria, including diffuse large B-cell lymphoma and transformed follicular lymphoma
- Relapsed or refractory disease after at least two cycles of treatment including anthracycline, cyclophosphamide, and rituximab or other CD20-targeting drugs
- Not eligible for or unwilling to have autologous hematopoietic stem cell transplantation; patients with recurrence or progression after stem cell transplantation
- Venous access suitable for mononuclear cell collection with hemoglobin ≥70 g/L, neutrophils ≥1.0x10^9/L, platelets ≥50x10^9/L
- At least one measurable lesion as per 2014 Lugano criteria
- Adequate organ function, including bone marrow function, creatinine ≤1.5 times upper limit of normal or creatinine clearance >30 mL/min/1.73 m2, liver enzymes ≤3 times upper limit of normal (≤5 times if liver metastasis), total bilirubin ≤2 times upper limit of normal (≤3 if Gilbert's syndrome or liver invasion), lung function with dyspnea grade ≤1 and oxygen saturation ≥92%, cardiac function with left ventricular ejection fraction ≥50%, no significant pericardial effusion
You will not qualify if you...
- History of other malignant tumors within 5 years except treated cervical carcinoma in situ, certain skin cancers, and localized adenocarcinoma or ductal carcinoma in situ after surgery
- Positive for hepatitis B surface antigen or core antibody with high HBV DNA, positive hepatitis C antibody with high HCV RNA, positive HIV antibody, or positive syphilis serology
- Unstable cardiac or cerebrovascular diseases within 6 months, including angina, stroke, myocardial infarction, heart failure (NYHA class ≥III), severe arrhythmias, recent angioplasty or bypass surgery, recent deep vein thrombosis or pulmonary embolism
- Lymphoma involving only the central nervous system except secondary CNS lymphoma
- Significant CNS history or disease such as epilepsy, stroke, dementia, Parkinson's, or severe brain injury
- Active autoimmune disease within 2 years except controlled hypothyroidism
- Active or uncontrolled infection needing systemic treatment within 14 days
- Active tuberculosis during screening
- Lymphoma lesions in lung or gastrointestinal tract at risk of bleeding
- Ongoing systemic steroid therapy or recent use within 72 hours before cell infusion
- Previous CAR-T therapy except CD19-targeted CAR-T with specific response criteria
- Recent autologous stem cell transplantation within 6 weeks
- Grade ≥2 graft-versus-host disease requiring treatment within 4 weeks or ongoing chronic GVHD
- Recent treatment with certain immunosuppressive drugs or chemotherapy within specified time frames
- Recent radiotherapy within 6 weeks unless meeting specific PET criteria
- Unresolved acute side effects from prior treatments above grade 1 except hematologic toxicity and alopecia
- Severe allergies or intolerance to study drugs
- Recent blood transfusions or growth factor treatments within specified periods
- Pregnancy, breastfeeding, or planning pregnancy within 1 year after treatment
- Any condition that may compromise safety, adherence, or study objectives as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ruijin hospital
Shanghai, China
Actively Recruiting
Research Team
W
Weili Zhao, MD
CONTACT
Z
Zixun Yan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here