A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)

The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.

The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.

The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.

Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.

Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.

Inclusion Criteria

• Participants must have measurable disease.
• Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment.
• Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening.
• Participants that have Relapsed or refractory FL, as assessed by the Investigator.
• Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent.
• Participants that received one prior line of systemic therapy are eligible if they present with high risk features.

Exclusion Criteria

• Participants must not have any history of heart problems.
• Participants must not have any bleeding disorders.
• Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions.
• Other protocol-defined Inclusion/Exclusion criteria apply.