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Lyell Immunopharma (LYEL)
NASDAQ:LYEL
Lisocabtagene Maraleucel, Rondecabtagene Autoleucel, Axicabtagene Ciloleucel
Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell Lymphoma, Non-Hodgkin Lymphoma Refractory/ Relapsed, Lymphoma, B-Cell, Diffuse Large B Cell Lymphoma (Dlbcl), Relapsed Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B Cell Lymphoma Relapsed
Phase III
Not Yet Recruiting
A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
Sep 16, 2025
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Impt-514
Lupus Nephritis, Systemic Lupus Erythematosus
Phase I/II
Withdrawn
A Study of IMPT-514 in Active Refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE)
Nov 22, 2023
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Cyclophosphamide, Fludarabine, Lyl314
Refractory Non-Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Large B-Cell Lymphoma, Relapsed Non-Hodgkin Lymphoma
Phase I/II
Recruiting
Study of LYL314 in Aggressive Large B-Cell Lymphoma
Mar 24, 2023
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Lyl845
Melanoma, Colorectal Cancer, Non-small Cell Lung Cancer
Phase I
Terminated
A Study to Investigate LYL845 in Adults With Solid Tumors
Oct 06, 2022
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Lyl797
Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Ovarian Cancer, Non-small Cell Lung Cancer, Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Nsclc, Relapsed Cancer, Endometrial Cancer, Non Small Cell Lung Cancer Metastatic, Tnbc - Triple-Negative Breast Cancer, Recurrent Breast Cancer, Platinum-Resistant Ovarian Cancer, Advanced Breast Cancer, Ovarian Epithelial Cancer, Nsclc Stage Iv, Non-Small Cell Carcinoma Of Lung, Tnm Stage 4, Advanced Lung Carcinoma, Nsclc, Recurrent, Relapse/Recurrence, Recurrent Nsclc, Endometrioid Tumor, High Grade Serous Carcinoma
Phase I
Terminated
A Study to Investigate LYL797 in Adults With Solid Tumors
Feb 18, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Lyell Immunopharma (LYEL) have in its pipeline
LYEL is currently developing the following drugs: Lisocabtagene Maraleucel, Rondecabtagene Autoleucel, Axicabtagene Ciloleucel, Impt-514, Cyclophosphamide, Fludarabine, Lyl314. These drug candidates are in various stages of clinical development as the company works toward FDA approval.