Actively Recruiting
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
Led by Shanghai Tongji Hospital, Tongji University School of Medicine · Updated on 2024-04-19
12
Participants Needed
1
Research Sites
834 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, open-label, single-dose clinical trial of anti-CD19-CAR-T cell therapy in relapsed/refractory B-cell tumor patients after Qinglin pre-treatment. In this study phase, a traditional "3+3" trial design is employed for dose escalation.
CONDITIONS
Official Title
Anti-CD19-CAR-T Cells in Relapsed/Refractory B-cell Tumor Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with informed consent and ability to comply with study procedures
- Age between 18 and 70 years
- Relapsed or refractory after standard treatments including stem cell transplantation and unsuitable for further transplantation
- Diagnosed with relapsed/refractory B-cell acute lymphoblastic leukemia or non-Hodgkin lymphoma as defined by specific relapse criteria
- Bone marrow tumor cells ≥5% in acute lymphoblastic leukemia patients
- Diagnosed with specific subtypes of non-Hodgkin lymphoma including DLBCL-NOS, PMBCL, transformed follicular lymphoma, mantle cell lymphoma, high-grade B-cell lymphoma, or CLL/SLL
- ECOG performance status ≤2
- Estimated life expectancy of at least 12 weeks
- Adequate venous access for blood collection
- Laboratory values within defined limits including neutrophils, hemoglobin, platelets, lymphocytes, liver and kidney function
- Left ventricular ejection fraction ≥45% with no significant heart abnormalities
- Baseline oxygen saturation >92% on room air
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Central nervous system involvement with CNS-2 or CNS-3 disease or evidence of CNS lymphoma on MRI without effective treatment
- Active neurological diseases or autoimmune diseases involving the central nervous system
- History or current other malignancies besides CD19-positive malignancies
- Significant cardiac diseases or uncontrolled arrhythmias
- Uncontrolled infections requiring intravenous antibiotics
- Positive for hepatitis B or C, syphilis, or HIV infection
- Presence of indwelling catheters or drainage tubes (except central venous access devices)
- Prior treatment with CD19-targeted therapy or recent use of specified medications and therapies before enrollment
- Active graft-versus-host disease grade ≥2 or requiring systemic steroids above physiological doses
- History of autoimmune diseases causing organ damage or requiring systemic therapy within 2 years
- Recent significant cardiac events within 12 months
- Genetic syndromes associated with bone marrow failure
- Symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulation within past 6 months
- Concurrent malignancies except certain treated types within past five years
- Use of other investigational drugs within 30 days prior to screening
- Pregnant or lactating women and those unwilling to use contraception
- Any medical condition that may interfere with study safety or assessments
- Inability or unwillingness to complete all study visits and procedures
- Previous use of CAR-T cell or genetically modified T cell therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China, 200333
Actively Recruiting
Research Team
A
Aibin Liang
CONTACT
P
Ping LI
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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