Actively Recruiting
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
Led by Shanghai Cell Therapy Group Co.,Ltd · Updated on 2025-08-21
20
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed or refractory B cell non-Hodgkin lymphoma.
CONDITIONS
Official Title
A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed or Refractory B Cell Non-Hodgkin Lymphoma(NHL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with relapsed or refractory B cell non-Hodgkin lymphoma including diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, transformation follicular lymphoma, or high grade B-cell lymphoma
- Refractory disease defined by no response or stable disease to last therapy, or relapse/progression within 12 months after autologous stem cell transplant
- Received prior therapy including anti-CD20 monoclonal antibody and anthracycline chemotherapy
- Immunohistochemical staining positive for at least two of CD19, CD20, BCMA
- At least one measurable lesion during screening
- Life expectancy of 12 weeks or more
- ECOG performance status of 0 or 1
- Adequate renal, hepatic, pulmonary, and cardiac function
- Adequate bone marrow function including minimum levels of neutrophils, lymphocytes, platelets, and hemoglobin
- Agree to use effective contraception until CAR-T cells are no longer detected
You will not qualify if you...
- Prior antiCD45 or antiCD3 therapy
- Detectable cerebrospinal fluid malignant cells, brain metastases, or history of CNS lymphoma
- History of CNS disorders such as seizure disorder, cerebrovascular disease, dementia, cerebellar disease, or autoimmune diseases with CNS involvement
- History of allogeneic stem cell transplantation
- Positive for hepatitis B surface antigen or other hepatitis B markers with active viral DNA
- Positive for hepatitis C RNA
- Positive for HIV or treponema pallidum
- Active or life-threatening infections requiring IV antimicrobials
- Unstable angina or recent myocardial infarction within 6 months, or severe uncontrolled diseases
- Uncontrolled arrhythmia under treatment
- Pregnancy or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, China, 201800
Actively Recruiting
Research Team
J
Jinxing Lou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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