On June 2, 2026 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech or the Company), a global leader in cell therapy, reported that promising preliminary clinical data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (R/R B-NHL), will be presented during a late-breaking session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress, taking place June 11-14, 2026, in Stockholm, Sweden.

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"The upcoming presentation of Phase 1 LB2501 data in patients with B-cell malignancies represents an important step in advancing in vivo CAR-T approaches," said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. "By generating CAR-T cells directly within the patient, this approach has the potential to simplify treatment delivery and expand access for patients who may not be able to receive traditional CAR-T cell therapies. LB2501 is built on the TaVec platform, which is a proprietary lentiviral vector engineered to enhance T-cell specificity, transduction efficiency, and safety, while restricting transduction of non-T cells."

LB2501: Promising Phase 1 Trial of In Vivo CAR-T Data Demonstrate High Response Rates in B-cell Malignancies

Data from 12 patients across two dose cohorts in an ongoing Phase 1 study evaluating LB2501 in patients with R/R B-NHL provide early clinical evidence supporting the potential of an in vivo CAR-T approach in B-cell malignancies. LB2501 is designed to generate CAR-T cells directly within the patient following a single intravenous infusion, eliminating the need for cell manufacturing and lymphodepletion.

As of April 1, 2026, 12 patients with R/R B-NHL were treated across two dose levels (DL1 and DL2). Additional details will be presented at EHA (Free EHA Whitepaper) 2026. Key findings from the abstract include:

Efficacy Results

At DL2 (median follow-up for DL2 was 2.2 months [range, 2.0 to 3.8])
Objective response rate (ORR): 100% (6/6)
Complete response rate (CR): 83.3% (5/6)
All responses were ongoing at data cutoff

Pharmacokinetics

Dose-dependent in vivo CAR-T expansion observed
CAR-T cells detected in peripheral blood for up to 116 days

Safety Results

No dose-limiting toxicities (DLTs), serious adverse events (SAEs), or deaths were observed
Infusion-related reactions occurred in 75% of patients, all of which were ≤ Grade 2
Cytokine release syndrome (CRS) occurred in 66.7% of patients, all of which were ≤ Grade 2
No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported
Grade ≥3 lentiviral vector-related and CAR-T-related adverse events were limited to decreased lymphocyte count and decreased neutrophil count

EHA Presentation (June 11-14, 2026)

Abstract No. Title Information
Abstract #LB5006
Late-Breaking Oral Presentation First-in-human trial of LB2501, an in vivo CD19/CD20 dual targeting CAR-T therapy, in relapsed/refractory B-Cell NHL

Session ID: s204
Date/Time: Sunday, June 14, 2026, 9:15-10:45 AM CEST
Location: Nobel Hall

ABOUT LB2501
LB2501 is an investigational, potential first-in-class CD19/CD20 dual-targeting in vivo CAR-T therapy designed to generate CAR-T cells directly within the patient following a single intravenous infusion. It is being evaluated in an ongoing Phase 1, open-label study NCT07002112) in patients with relapsed/refractory B-cell malignancies to assess safety, tolerability, and preliminary efficacy.i

ABOUT B-CELL NON-HODGKIN LYMPHOMA
Non-Hodgkin lymphoma (NHL) is a group of cancers that originate in lymphocytes, a type of white blood cell that plays a key role in the body’s immune system.ii B-cell lymphomas account for approximately 85% of NHL cases and arise from abnormal growth of B lymphocytes (B cells), which are responsible for producing antibodies. These malignancies include a range of subtypes that vary in aggressiveness, from slow-growing to highly aggressive disease.

(Press release, Legend Biotech, JUN 2, 2026, View Source [SID1234666402])