Yescarta (axicabtagene ciloleucel)

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2027 --> Jul 2027 | Trial primary completion date: Jan 2027 --> Jul 2027

P2, N=120, Recruiting, Australasian Leukaemia and Lymphoma Group | Not yet recruiting --> Recruiting | N=24 --> 120

CAR-T products achieved overall response rates (ORR) of 52-83% and complete response (CR) rates of 40-58%; randomized second-line trials favored axicabtagene ciloleucel and lisocabtagene maraleucel over standard care...BsAbs were active in heavily pretreated disease (epcoritamab ORR 50%/CR 44%; glofitamab ORR 55%/CR 35%), with predominantly low-grade cytokine release syndrome. Selinexor showed more modest efficacy (ORR 39%/CR 16%) but durable benefit in complete responders.ConclusionsCurrent evidence supports a stepwise treatment framework: DLBCL-like induction at transformation, autologous stem-cell transplant in fit, chemosensitive responders, CAR-T as the preferred option at first relapse, BsAbs after CAR-T or when cellular therapy is not feasible, and selinexor in later-lines of therapy. Additional prospective t-FL-inclusive trials are needed to refine treatment selection and biomarker-guided sequencing.

Axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel) are standard-of-care second-line therapies for relapsed or refractory large B-cell lymphomas, yet clinical and immunological predictors of durable benefit remain poorly defined. Greater CART expansion, enrichment for naïve CD8+ CAR+ T-cells, and lower PD1 expression at day 7 post-infusion are associated with response. Thus, these findings highlight the efficacy of second-line CART and identify disease and immune-related predictors of long-term response.

P2, N=20, Recruiting, Zhejiang Cancer Hospital | Not yet recruiting --> Recruiting

P3, N=550, Recruiting, Kite, A Gilead Company | Not yet recruiting --> Recruiting

Axi-cel demonstrated substantial efficacy in Japanese patients with r/r LBCL. The 2L setting was associated with higher toxicity and numerically higher PFS.

We conducted a multicenter retrospective study using the French DESCAR-T registry, including patients with LBCL who relapsed after 2L CAR T-cell therapy with axicabtagene ciloleucel or lisocabtagene maraleucel. This study represents the first real-world analysis of outcomes after relapse following 2L CAR T-cell therapy. Despite the more frequent incorporation of BsAbs into the therapeutic landscape, overall prognosis and treatment efficacy remain dismal, highlighting the urgent need for innovative therapeutic strategies and dedicated prospective trials in this emerging double-refractory population.

P2, N=20, Not yet recruiting, Zhejiang Cancer Hospital

We report a case of severe, irreversible transverse myelitis following CD19-directed CAR-T cell therapy (axicabtagene ciloleucel) for refractory post-transplant lymphoproliferative disorder (PTLD) in a young female lung-transplant recipient...We further address diagnostic challenges, and review current management strategies such as corticosteroids, IL-1 blockade, and IL-6 neutralization. This report underscores the need for heightened vigilance, early imaging, and systematic reporting to improve prevention and treatment of this rare but severe CAR-T-related neurotoxicity.

P3, N=300, Active, not recruiting, Kite, A Gilead Company | Recruiting --> Active, not recruiting

These findings highlight the importance of early leukapheresis, ideally before intensive treatments, to optimize T-cell yield, product quality, and therapeutic efficacy.