Actively Recruiting
CD19/CD22 CAR-T as First-line Consolidation in Follicular Lymphoma
Led by Liping Dou · Updated on 2026-05-14
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the efficacy and safety of CD19/CD22 Chimeric Antigen Receptor (CAR) T-Cell immunotherapy as first-line consolidation therapy in patients with follicular lymphoma.
CONDITIONS
Official Title
CD19/CD22 CAR-T as First-line Consolidation in Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent and agree to follow study visits, treatments, and tests
- Diagnosed with CD19 and/or CD22-positive follicular lymphoma per WHO classification
- Disease status is partial response after standard first-line chemotherapy or complete response with high-risk factors
- Have at least one high-risk feature such as FLIPI score 3-5, lymph node or extranodal mass >6 cm, significant macrophage infiltration, TP53 or NOTCH1 mutation, 1p36 deletion or 1q amplification, or m7-FLIPI high-risk subtype
- Age between 18 and 85 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Expected survival longer than 3 months
- Hemoglobin level ≥ 60 g/L
- Neutrophil count ≥ 1000/µL and platelet count ≥ 45000/µL
- Liver and kidney functions within specified limits (bilirubin, ALT, AST, creatinine, creatinine clearance)
- Heart and lung functions meeting specific criteria including left ventricular ejection fraction ≥ 50%, oxygen saturation > 92%, no significant pleural effusion
- Agree to use contraception for 6 months if having pregnancy plans and notify if pregnant or suspected pregnant
You will not qualify if you...
- Prior receipt of any CAR cell therapy or genetically modified T cell therapy
- History of severe immediate hypersensitivity reactions to aminoglycoside antibiotics or other essential medications
- Known HIV infection, active hepatitis B infection, or uncontrolled systemic infections requiring IV antibiotics
- Liver and kidney dysfunction related to non-hematological tumors beyond defined limits
- Recent serious cardiovascular events or unstable heart conditions within past 12 months
- Serious other medical conditions that may affect study participation or safety
- History of severe allergies to medications or biological products needed in this study
- Currently pregnant or breastfeeding females
- Unable or unwilling to complete all study visits or follow-up as determined by the researcher
- History of other malignant tumors unless disease-free and off anti-tumor treatment for at least 3 years
- Receipt of live vaccines within 6 weeks before starting treatment
- Underwent major surgery within past 14 days or expected to require major surgery during treatment
- Other severe physical or mental illnesses or lab abnormalities increasing risk or affecting study results, or deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
Research Team
L
Li-Ping Dou Dr.
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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