Lyell Immunopharma, Inc. ((LYEL)) announced an update on their ongoing clinical study.
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Lyell Immunopharma, Inc. is conducting a Phase 3 clinical trial titled A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel, an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Versus Investigator’s Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting. The study aims to evaluate the efficacy of rondecabtagene autoleucel (ronde-cel) compared to existing CD19 CAR T-cell therapies in treating patients with relapsed or refractory large B-cell lymphoma.
The intervention being tested is rondecabtagene autoleucel, a biological therapy designed to target both CD19 and CD20 proteins on cancer cells. This dual-targeting approach is intended to improve treatment outcomes for patients.
The study is designed as a randomized, parallel assignment with no masking, focusing on treatment as its primary purpose. This means participants are randomly assigned to either the experimental group receiving ronde-cel or the active comparator group receiving investigator’s choice of CD19 CAR T-cell therapy.
The study is set to begin on September 16, 2025, with the primary completion and estimated completion dates yet to be announced. The last update was submitted on the same date, indicating the study’s planning phase is ongoing.
This clinical trial could significantly impact Lyell Immunopharma’s stock performance and investor sentiment, particularly if the results demonstrate superior efficacy of ronde-cel over existing treatments. This development could position Lyell as a key player in the competitive CAR T-cell therapy market.
The study is currently not yet recruiting, with further details available on the ClinicalTrials portal.