Legend Biotech Establishes Clinical Proof-of-Concept for LB2501, a Potential First-in-Class In Vivo CD19/CD20 Dual-Targeting CAR-T, in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma
Rhea-AI Summary
Legend Biotech (NASDAQ: LEGN) reported first clinical proof-of-concept for LB2501, an investigational in vivo CD19/CD20 dual-targeting CAR-T, in relapsed/refractory B-cell non-Hodgkin lymphoma. In a Phase 1 trial, a single infusion at the higher dose achieved 100% ORR and 83.3% CR without lymphodepletion.
LB2501 showed dose-dependent in vivo CAR-T expansion, Grade 1–2 IRR/CRS only, no DLTs, SAEs, ICANS, or deaths, plus rapid vector clearance and polyclonal vector integration.
Positive
- DL2 showed 100% ORR (6/6) and 83.3% CR (5/6) after single infusion
- Responses at DL2 were all ongoing at data cutoff
- Study conducted without lymphodepletion while still achieving in vivo CAR-T expansion
- No DLTs, SAEs, ICANS, or deaths reported in 12 treated patients
- IRR and CRS limited to Grade 1–2; no glucocorticoids needed for CRS
- CAR-T expansion seen in 100% of DL2 and 83% of DL1 patients
- CAR-T cells detectable in blood for up to 116 days
- Rapid vector clearance to undetectable levels within 24 hours
- Translational data showed polyclonal vector integration and no non-specific transduction
Negative
- Phase 1 dataset is small, with only 12 total treated patients
- Across both dose levels, ORR was 50.0% and CR rate 41.7%
- Infusion-related reactions occurred in 75.0% of patients
- Cytokine release syndrome occurred in 66.7% of patients, despite being Grade 1–2
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 02 | LB2501 EHA preview | Positive | +42.2% | Initial in vivo LB2501 data with 100% ORR and favorable safety at DL2. |
| Jun 01 | ASCO data update | Positive | -6.1% | First-in-human LB2102 and new CARVYKTI data with manageable safety profile. |
| May 21 | ASCO presentations plan | Positive | +4.9% | Announcement of multiple CAR-T presentations and investor event at ASCO 2026. |
| May 12 | Q1 2026 earnings | Positive | +10.5% | Strong CARVYKTI growth, revenue increase, narrowed losses, and solid cash. |
| May 04 | Advisory board expansion | Positive | +12.3% | New scientific advisors to guide next‑generation cell therapy pipeline. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
LEGN has mostly seen positive price alignment with constructive news, particularly around CAR-T clinical updates and earnings, with only one notable divergence on broadly positive clinical data.
Over the past two months, Legend Biotech has reported multiple milestones. On May 12, 2026, strong Q1 results and CARVYKTI® growth saw a 10.48% gain. Scientific advisory expansion on May 4 coincided with a 12.34% rise. ASCO 2026 presentation news on May 21 and detailed LB2102/CARVYKTI data on June 1 produced mixed reactions, including a -6.08% move. Importantly, early LB2501 data similar to today’s announcement on June 2 drove a 42.22% jump, underscoring market sensitivity to this in vivo CAR-T program.
Key Terms
car-t medical
objective response rate medical
complete response rate medical
cytokine release syndrome medical
immune effector cell-associated neurotoxicity syndrome medical
lymphodepletion medical
pharmacokinetics medical
in vivo medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Achieved
100% ORR and83.3% CR rate at dose level 2 following a single infusion in patients with relapsed/refractory B-NHL in an ongoing Phase 1 study - Single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion
- No dose-limiting toxicities, serious adverse events, ICANS, or deaths were reported; infusion-related reactions and CRS were Grade 1–2, and none required glucocorticoids for CRS management
- Additional translational data showed rapid vector clearance, polyclonal vector integration, and no evidence of non-specific transduction
- Proof-of-concept progress demonstrates leadership in next-generation cell therapies, with results presented in a late-breaking session at EHA 2026
BRIDGEWATER, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced first clinical proof-of-concept data for LB2501, its investigational in vivo CD19/CD20 dual-targeting CAR-T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL). The results are being presented today in a late-breaking session at the European Hematology Association (EHA) 2026 Congress (Abstract #LB5006).
In the ongoing Phase 1 study, a single infusion of LB2501 generated dose-dependent in vivo CAR-T expansion without lymphodepletion. At the higher dose level (DL2), LB2501 achieved a
“In vivo CAR-T represents a compelling frontier in cell therapy, enabling the generation of CAR-T cells directly within the patient, with the potential to simplify treatment and expand access over time,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “LB2501 is our step toward realizing that vision and reflects further progress toward our goal of leading the future of cell therapy. Backed by the commercial and scientific foundation we have built with CARVYKTI, we are well-positioned to advance this next generation of CAR-T delivery. These early data, with deep responses from a single infusion across patients, give us confidence in the path ahead.”
LB2501 Demonstrates In Vivo CAR-T Generation and Early Clinical Activity
In an ongoing Phase 1 study, 12 patients with R/R B-NHL received LB2501 across two dose levels, DL1 (n=6) and DL2 (n=6). Patients had received a median of three prior lines of therapy, and
At DL2, LB2501 achieved a
LB2501 showed a favorable safety profile. No DLTs, SAEs, ICANS, or deaths were reported. Infusion-related reactions (IRR) and cytokine release syndrome (CRS) were the most common adverse events of special interest and were all Grade 1–2. Infusion-related reactions occurred in
Pharmacokinetic analyses showed dose-dependent in vivo CAR-T expansion in
Additional translational analyses further characterized the in vivo profile of LB2501. No evidence of non-specific transduction was detected in NK cells or other non-T/B/NK lymphocyte populations. Vector integrations were highly polyclonal and diverse. These findings support proof-of-concept for in vivo T-cell engineering, with polyclonal vector integration and rapid vector clearance.
“These early clinical findings are encouraging in a heavily pretreated relapsed or refractory B-cell non-Hodgkin lymphoma population,” said Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China. “The responses observed at the higher dose level achieved a
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 malignanciesi 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
While treatment advances have improved outcomes for some patients, those with relapsed or refractory B-cell NHL, particularly after multiple lines of therapy, often face limited options.
ABOUT LEGEND BIOTECH
With over 3,000 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. Legend Biotech is at the forefront of the CAR-T cell therapy revolution with CARVYKTI®, a one-time treatment for relapsed or refractory multiple myeloma, which it develops and markets with collaborator Johnson & Johnson. Centered in the United States, Legend Biotech is building an end-to-end cell therapy company by expanding its leadership to maximize CARVYKTI’s patient access and therapeutic potential. From this platform, Legend Biotech plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.
Learn more at https://legendbiotech.com and follow us on X, Instagram, and LinkedIn.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, the Phase 1 clinical trial of LB2501, and the potential benefits of LB2501, including the reproducibility and durability of any favorable results initially seen in patients dosed to date in clinical trials, and LB2501’s potential to be first-in-class. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by Legend Biotech’s third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 10, 2026. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
‡ Lei Fan, M.D., Ph.D., Professor, Doctoral Supervisor, and Administrative Director, Hematology Department, Jiangsu Province Hospital, Nanjing, China, has provided consulting and advisory services to Legend Biotech; he has not been paid for any media work.
INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
investor@legendbiotech.com
PRESS CONTACT:
Kim Fox
Tel: (848) 388-8445
media@legendbiotech.com
i ClinicalTrials.Gov. The CD19/ CD20 Dual-Target in Vivo CAR-T Lentiviral Product in the Treatment of Relapsed/ Refractory B-cell Malignancies. https://clinicaltrials.gov/study/NCT07002112. Accessed May 2026
ii American Cancer Society. “What Is Non-Hodgkin Lymphoma?”. Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html.Accessed May 2026.
iii American Cancer Society. “Types of B-cell Lymphoma.” Available at: https://www.cancer.org/cancer/types/non-hodgkin-lymphoma/about/b-cell-lymphoma.html.Accessed May 2026.
