Actively Recruiting
Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma
Led by Shanghai First Song Biotechnology Co., LTD · Updated on 2024-09-19
9
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an exploratory clinical trial of a single-center, open-label, single-dose treatment of anti-CD20/CD30-CAR-T cells in subjects with relapsed/refractory lymphoma.
CONDITIONS
Official Title
Safety and Efficacy of Anti-CD20/CD30 CAR-T Cells in Subjects with Relapsed/Refractory Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 to less than 70 years
- Voluntary participation with signed informed consent and ability to follow all study procedures
- Relapsed or refractory lymphoma after standard treatments, including stem cell transplantation, unsuitable for other treatments
- Lymphoma expressing CD20 and/or CD30 antigens, including relapsed after anti-CD19-CAR-T therapy
- Specific lymphoma subtypes: DLBCL-NOS, PMBCL, transformed follicular lymphoma, mantle cell lymphoma, high-grade B-cell lymphoma, CLL/SLL, Hodgkin lymphoma
- ECOG performance status of 2 or less
- Expected survival of at least 12 weeks
- Adequate venous access for blood cell collection and no contraindications
- Laboratory values within specified limits including neutrophils, hemoglobin, platelets, liver and kidney function
- Ejection fraction at least 45% and no significant echocardiogram or electrocardiogram abnormalities
- Baseline oxygen saturation greater than 92% without supplemental oxygen
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Central nervous system lymphoma or active CNS diseases unless effectively treated and asymptomatic for over 4 weeks
- Other active central nervous system diseases such as epilepsy or autoimmune CNS involvement
- History or current diagnosis of malignancies other than CD19+ cancers
- Clinically significant uncontrolled heart disease or arrhythmias
- Active infections requiring intravenous antibiotics except uncomplicated urinary tract or bacterial pharyngitis
- Positive for active hepatitis B or C, syphilis, or HIV infection
- Presence of indwelling catheters or drainage tubes except specialized central venous access devices
- Recent use of certain medications including lenalidomide, idelalisib, targeted therapies, venetoclax, growth factors, corticosteroids, radiation, systemic cytotoxic drugs, immune therapies, live vaccines, donor lymphocyte infusion within specified timeframes before enrollment
- Active graft-versus-host disease requiring systemic steroids above physiological levels
- Autoimmune diseases with organ damage or requiring systemic immunosuppression within past 2 years
- Recent significant cardiac events within 12 months
- Genetic bone marrow failure syndromes
- Recent symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Other malignancies effectively controlled without treatment within past 5 years
- Use of other investigational drugs within 30 days before screening
- Pregnant or breastfeeding women or those unwilling to use contraception until 12 months post-treatment
- Any medical condition or activity that could interfere with study safety or efficacy evaluation
- Inability or unwillingness to complete all study visits and procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
Research Team
H
Huaying Ruan
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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