Press Releases June 4, 2026 04:05 PM

Lyell Immunopharma to Present Phase 1/2 Safety and Translational Data for Ronde-Cel in Large B-Cell Lymphoma at the European Hematology Association 2026 Congress

Lyell Immunopharma to present promising Phase 1/2 data on ronde-cel CAR T-cell therapy for large B-cell lymphoma at EHA 2026.

By Priya Menon LYEL

Lyell Immunopharma announced it will present updated safety and translational data from its Phase 1/2 trial of rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, in relapsed or refractory large B-cell lymphoma at the European Hematology Association Congress 2026. The data highlight low-grade side effects and durable clinical responses. The company is conducting pivotal trials for regulatory submissions expected in 2027.

Lyell Immunopharma to Present Phase 1/2 Safety and Translational Data for Ronde-Cel in Large B-Cell Lymphoma at the European Hematology Association 2026 Congress
LYEL

Key Points

  • Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell therapy showing promising safety with low-grade CRS and ICANS in LBCL patients.
  • Two pivotal clinical trials are ongoing: PiNACLE for third-line or later patients with data expected mid-2027, and PiNACLE-H2H Phase 3 comparing ronde-cel to standard CAR T therapies in second-line disease.
  • Lyell possesses manufacturing capacity to potentially produce over 1,200 CAR T doses annually, supporting commercial launch plans.

SOUTH SAN FRANCISCO, Calif., June 04, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that the Company will present data from its ongoing Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) at the European Hematology Association (EHA) 2026 Congress, taking place in Stockholm, Sweden, June 11–14, 2026. The data will be featured in two poster presentations covering an updated ronde-cel safety analysis and translational insights.

EHA 2026 Poster Presentations

Low-Grade CRS and ICANS with Rondecabtagene Autoleucel, a Dual-Targeting CD19/CD20 CAR T-Cell Product Candidate, in Patients with Large B-Cell Lymphoma: Updated Safety Analysis

  • Poster: PF962
  • Session: Large B-Cell Lymphomas – Clinical; Hall A
  • Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
  • Presenting Author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA

Durable Responses with Rondecabtagene Autoleucel (Dual-Targeting CD19/CD20 CAR
T-Cells) are Associated with Higher Proportion of Cytotoxic T Cells with Memory Potential in Infusion Products

  • Poster: PF1097
  • Session: Lymphoma Biology & Translational Research; Hall A
  • Time: Friday, June 12, 12:45 pm EDT / 6:45 pm CEST
  • Presenting Author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center

Ronde-cel is currently being evaluated for the treatment of R/R LBCL across two pivotal clinical trials. In the 3L+ setting, the ongoing single-arm PiNACLE trial is expected to report updated data in the second half of 2026 and pivotal data by mid-2027, setting up a subsequent Biologics License Application (BLA) submission in 2027. In the 2L setting, the Phase 3 randomized PiNACLE-H2H trial is evaluating ronde-cel against investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel.

The posters will be available through the Science section of the Company's website at www.lyell.com after the presentations.

About Lyell Immunopharma, Inc.

Lyell is a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with hematologic malignancies and solid tumors. To realize the potential of cell therapy for cancer, Lyell utilizes a suite of technologies to arm CAR T cells with enhancements needed to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical responses, including the ability to resist exhaustion, maintain qualities of durable stemness and function in the hostile tumor microenvironment. LyFE has commercial launch capability and is expected to have the capacity to manufacture more than 1,200 CAR T-cell doses per year. To learn more, please visit www.lyell.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell's planned presentations at a medical congress; the potential clinical benefits and therapeutic potential of Lyell’s product candidates; and the sufficiency of the capacity of LyFE to manufacture drug supply through potential commercial launch. These statements are based on Lyell’s current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties described under the heading “Risk Factors” in Lyell’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the Securities and Exchange Commission on May 6, 2026. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law.

Contact:

Pablo Fenton
Associate Director, Investor Relations and Corporate Communications
[email protected] 


Risks

  • Clinical trial results may not meet regulatory requirements or show sufficient efficacy and safety, delaying or preventing approval.
  • Competition from existing CAR T-cell therapies like axicabtagene ciloleucel and lisocabtagene maraleucel could impact commercial success.
  • Manufacturing scale-up or supply chain challenges could affect availability and timely launch, impacting revenue projections.

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