A Study of CD19/CD22 CAR-T Cell Therapy as First-line Consolidation Treatment in Patients With Follicular Lymphoma
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.
• 1\. With the patient's consent and signed informed consent form, willing and able to comply with the planned visits, research treatments, laboratory tests, and other experimental procedures;
• 2\. CD19 and/or CD22-positive follicular lymphoma (FL) confirmed by histology according to the WHO classification:
‣ The patient's disease is still evaluated as partial response (PR) after induction treatment with standard first-line chemotherapy regimen, or
⁃ The patient's disease reaches complete response (CR) after induction treatment with standard first-line chemotherapy regimen, but there are high-risk factors at the time of onset;
• 3\. The possible high-risk factors for the patient's onset of the disease are as follows: Presence of at least one of the following high-risk features at diagnosis:
‣ Follicular Lymphoma International Prognostic Index (FLIPI-1) score of 3-5 or FLIPI-2 score of 3-5;
⁃ Presence of any lymph node or extranodal mass \>6 cm in diameter;
⁃ Significant infiltration of CD68+ or CD163+ macrophages by immunohistochemistry;
⁃ Gene sequencing revealing TP53 or NOTCH1 mutation;
⁃ Presence of 1p36 deletion or 1q amplification;
⁃ Next-generation sequencing (NGS)-defined high-risk mutation-based 7-gene Follicular Lymphoma International Prognostic Index (m7-FLIPI) subtype.
• 4\. Age range from 18 to 85 years old, male or female;
• 5\. Subjects with physical fitness status scores ranging from 0 to 2 in the Eastern Cooperative Oncology Group (ECOG) in the United States;
• 6\. Expected survival period from the date of signing the informed consent form is greater than 3 months;
• 7\. HGB ≥ 60g/L;
• 8\. The absolute value of neutrophils in peripheral blood is ≥ 1000/μl, and the platelet count is ≥ 45000/μl;
• 9\. Liver and kidney function, as well as heart and lung function, meet the following requirements:
‣ Total bilirubin (TBIL) ≤ 1.5 times the upper limits of normal (ULN), except for subjects with Gilbert's syndrome;
⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN;
⁃ Serum Creatinine (Cr) ≤ 1.5 times ULN or Creatinine Clearance Rate (CCr) ≥ 60mL/min, estimated based on the Cockcroft Gault formula;
⁃ The left ventricular ejection fraction (LVEF) of the heart is ≥ 50%. Echocardiography (ECHO) confirms no pericardial effusion and no clinically significant arrhythmia;
⁃ Baseline transcutaneous oxygen saturation under indoor ventilation\>92%;
⁃ No clinically significant pleural effusion;
• 10\. Participants with pregnancy plans must agree to take contraceptive measures for a continuous period of 6 months from before enrollment in the study until the end of the study; If the subject is pregnant or suspected of being pregnant, the researcher should be notified immediately.