USO 25143
A PHASE 3 RANDOMIZED CONTROLLED STUDY OF LYL314, A DUAL-TARGETING CD19/CD20 INVESTIGATIONAL CAR-T-CELL THERAPY VERSUS APPROVED CD19 CAR-T-CELL THERAPY IN PATIENTS WITH RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA IN THE SECOND-LINE SETTING(LYL314-102)
Disease Types: CAR-T
Eligibility Requirements:
• Subjects must have histologically confirmed LBCL that includes
DLBCL, HGBCL with MYC and BCL2 rearrangements, HGBCL
NOS, FL3B, and transformations of indolent B-cell lymphomas
• Subjects must have relapsed or refractory disease after antiCD20 antibody- and anthracycline-containing first-line
chemotherapy
• Subjects must have a [18F]-fluorodeoxyglucose PET-positive
lesion at Screening per Lugano Criteria 2014
• Subjects with CNS lymphoma are excluded
• Subjects that received prior treatment with any allogeneic HCT,
gene therapy product, CAR-directed cell therapy, or T-cell
engager are excluded
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