NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma

Inclusion criteria

• ✓. Male or female ≥ 18 years of age at the time of consent.
• ✓. Received standard of care therapy with axi-cel or liso-cel (Stage 1 and Stage 2), or tisa-cel (Stage 2 only), for the respective FDA (or Summary of Product Characteristics \[SmPC\]) approved indication(s):
• ✓. liso-cel: Patients with LBCL (including diffuse LBCL \[DLBCL\] not otherwise specified \[including DLBCL arising from indolent lymphoma\], high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma Grade 3B), who have:
• ✓. refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy;
• ✓. refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or,
• ✓. relapsed or refractory disease after two or more lines of systemic therapy.
• ✓. axi-cel: For the treatment of adult patients with LBCL that is:
• ✓. refractory to first-line chemoimmunotherapy;

Exclusion criteria