Yescarta (axicabtagene ciloleucel)

This case, among the youngest reported uses of commercial Axi-cel for BL, highlights the diagnostic complexity in adolescent lymphoma and demonstrates that CD19 CAR-T therapy can overcome TP53-associated chemoresistance in adolescent BL. It also suggests that integrating molecular profiling and immunotherapy may provide new strategies for managing high-risk, treatment-refractory cases in the adolescent and young adult population.

P2, N=35, Completed, Kite, A Gilead Company | Active, not recruiting --> Completed

P2, N=396, Recruiting, SWOG Cancer Research Network | Trial completion date: Dec 2029 --> Jun 2030 | Trial primary completion date: Dec 2025 --> Jun 2030

P4, N=20, Not yet recruiting, Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

In apheresis, a cut-off value of >4.3% of CD8+ TCM predicted strong CAR-T expansion (AUC: 0.80; p = 0.023) and superior progression-free survival (p = 0.04) compared with patients who had CD8+ TCM below the cut-off. Our data suggest that high frequencies of CD8+ TCM cells in apheresis samples may represent a promising pre-treatment biomarker associated with strong CAR-T expansion and superior clinical outcome in r/r LBCL patients following axi-cel.

P1/2, N=30, Suspended, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026 | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> Sep 2026

P1, N=20, Recruiting, AIDS Malignancy Consortium | Trial completion date: Jan 2027 --> Jan 2029 | Trial primary completion date: Jan 2026 --> Jan 2028

To investigate this clinical issue, 106 patients treated with CAR-T cell therapy using either tisagenlecleucel, lisocabtagene maraleucel or axicabtagene ciloleucel for r/r DLBCL at our institution were retrospectively analyzed. Multivariate analysis revealed that CD5 expression was unfavorably associated with PFS and OS. Together, these data suggest that CD5 expression has a negative impact on outcomes after CAR-T cell therapy.

P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Nov 2025 --> Dec 2026

P1, N=37, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Dec 2026

P2, N=24, Not yet recruiting, Ruijin Hospital

Axi-cel plus rituximab treatment led to durable responses with no new safety signals despite persistent B cell aplasia and pharmacokinetics of axi-cel were unaffected, indicating that dual targeting of CD19 and CD20 is a feasible and safe approach to potentially limit antigen escape. ClinicalTrials.gov registration: NCT04002401 .