Clinical Design and Objectives This study is a Phase 2 evidence‑based (open‑label, multicenter) trial that commenced on June 14, 2024, and will enroll approximately 65 patients with relapsed/refractory aggressive large B‑cell lymphoma over an 18‑month period. Golidomide will be administered from Day 5 after CAR‑T cell infusion for a total of 24 weeks (six cycles). The primary endpoint is the complete metabolic response (CMR) rate at three months post‑CAR‑T infusion, directly reflecting therapeutic efficacy.

Differentiation from Current Treatment Landscape Currently, treatment of relapsed/refractory large B‑cell lymphoma relies on CD19‑targeted CAR‑T cell therapy followed by immunomodulators or high‑dose chemotherapy. However, patients at high risk of relapse after CAR‑T require ongoing suppression of the tumor microenvironment. Golidomide is expected to enhance immune cell function and provide additional tumor cell inhibition through a CELMoD mechanism.

Expected Benefits and Risks If the three‑month CMR rate shows a statistically significant increase compared with CAR‑T monotherapy, Golidomide could become a new standard for post‑CAR‑T maintenance. Conversely, if safety analysis leads to trial termination after only three patients, toxicities could emerge early, posing a risk. Therefore, safety monitoring is a critical determinant of clinical success.