A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Prior treatment

• Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
• Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.

Other illness

• Active CNS involvement by malignancy.
• Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
• Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).

Lab values

• Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.
  • Other protocol defined inclusion/exclusion criteria may apply

Other

• Follicular lymphoma grade 3B or evidence of histologic transformation.

• Age ≥ 18 years at the date of signing the informed consent form.
• Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
• Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
• Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
• ECOG performance status of 0, 1 or 2 at screening.
• Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
• Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
• Must be eligible for treatment with the selected standard of care regimen.