Clinical Summary: 

• Design/Population: An ongoing phase 1 study evaluated LB2501 in previously treated patients with relapsed or refractory B-cell non-Hodgkin lymphomas. 
• Key Outcomes: LB2501 demonstrated encouraging early activity, with responses observed across treated patients. Safety was favorable and pharmacokinetic analyses confirmed successful in vivo CAR T-cell generation, expansion, and persistence.
• Clinical Relevance: These findings represent the first reported clinical experience with in vivo CAR T-cell therapy in relapsed or refractory non-Hodgkin lymphoma and support further development of off-the-shelf CAR T-cell approaches.

Results from an ongoing phase 1 trial demonstrated that LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR T-cell therapy, showed encouraging activity and promising safety among patients with relapsed or refractory B-cell non-Hodgkin lymphomas. 

These results were presented by Lei Fan, MD, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China, at the 2026 European Hematology Association (EHA) Congress in Stockholm, Sweden. 

In this dose-escalation trial, 12 adult patients with measurable relapsed or refractory non-Hodgkin lymphomas, including large B-cell lymphoma (n = 7), follicular lymphoma (n = 3), and mantle cell lymphoma (n = 2), who had primary refractory disease or experienced disease progression following at least 2 prior lines of therapy received a single intravenous infusion of LB2501 without lymphodepletion. Dose escalation followed a 3+3 design across multiple dose levels. Primary end points included safety, pharmacokinetics, and preliminary objective response rate (ORR). 

At analysis, no dose-limiting toxicities, serious adverse events, or treatment-related deaths were reported. Infusion-related reactions were reported in 75% of patients and were all grade 1/2, resolving within 2 days without tocilizumab or corticosteroids. Cytokine release syndrome was reported in 66.7% of patients, with grade 1 events reported in 58.3% of patients and grade 2 events reported in 1 patient. No incidences of immune effector cell-associated neurotoxicity syndrome was reported. Grade ≥3 lentiviral vectors and CAR T-related adverse events were limited to decreased lymphocyte and neutrophil counts. 

The ORR was 50%, with 41.7% of patients achieving complete response. Among patients treated at dose level 2, ORR was 100%, with 83.3% of patients achieving complete response.  All responses remained ongoing at the time of data cutoff, although follow-up remained limited, with a median duration of 2.2 months at the higher dose level.

Pharmacokinetic analyses confirmed successful in vivo CAR-T generation and expansion. Dose-dependent CAR-T expansion was observed in 83% of patients at dose level 1 and 100% of patients at dose level 2. At the higher dose level, the median peak CAR-T concentration exceeded 109,000 copies/μg DNA, with a median time to peak expansion of 15 days. CAR-T cells remained detectable in peripheral blood for up to 116 days. Insertion site analyses demonstrated highly T-cell–specific transduction, polyclonal expansion, and predominantly single-copy vector integration.

“LB2501 … introduces a novel paradigm by eliminating the need for ex vivo manufacturing and lymphodepletion,” concluded Dr Fan. “While a longer-follow up is warranted, these data highlight the potential of LB2501 as a scalable, readily accessible ‘off‑the‑shelf’ immunotherapy for B‑cell malignancies.”

Source: 

Qu X, Zhang Y, Liu H, et al. First-in-human trial of LB2501, an in vivo CD19/CD20 dual targeting CAR-T therapy, in relapsed/refractory B-cell NHL. Presented at EHA Congress. June 11 - June 14, 2026. Stockholm, Sweden. Abstract EHA-7249.