CAR T-cell Therapy

Paul J. Shaughnessy, MD, discusses how CAR T-cell therapy is being utilized in hematologic malignancies, challenges faced with this modality, and ongoing research efforts being made to better leverage its use.

Tisagenlecleucel was found to elicit clinically meaningful activity in patients with relapsed/refractory follicular lymphoma, meeting the phase 2 ELARA trial’s primary end point of complete response rate.

Paul J. Shaughnessy, MD, discusses challenges with CAR T-cell therapy in relapsed/refractory hematologic malignancies.

A biologics license application has been submitted to the FDA for idecabtagene vicleucel for the treatment of adult patients with relapsed and refractory multiple myeloma.

The FDA has approved the CAR T-cell therapy brexucabtagene autoleucel (Tecartus; formerly KTE-X19) as a treatment for adult patients with relapsed/refractory mantle cell lymphoma.

The FDA has cleared an investigational new drug application for the first-of-its-kind, off-the-shelf CAR T-cell product FT819, which targets CD19-positive malignancies.

Paul J. Shaughnessy, MD, discusses the available CAR T-cell therapies for relapsed/refractory hematologic malignancies.

The European Medicines Agency has validated a Marketing Authorization Application for the CD19-directed CAR T-cell therapy lisocabtagene maraleucel for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and grade 3B follicular lymphoma following at least 2 prior therapies.

Advances of chimeric antigen receptor T-cell therapy technologies are in rapid development and under investigation in a range of preclinical and clinical research around the globe.

The FDA has issued a clinical hold on the phase 1 MELANI-01 trial evaluating the CAR T-cell product UCARTCS1A in the treatment of patient with relapsed/refractory multiple myeloma.

Nikhil C. Munshi, MD, discusses the next steps for research with idecabtagene vicleucel in relapsed/refractory multiple myeloma.

Natalie Sophia Grover, MD, discusses ongoing research with CAR T-cell therapy in hematologic malignancies, efforts examining the potential for this approach in solid tumors, and future directions and challenges with this modality.

Caron Jacobson, MD, discusses the initial ZUMA-5 findings and the next steps with axicabtagene ciloleucel in follicular lymphoma and marginal zone lymphoma.

Findings from an exploratory analysis of the phase 1/2 ZUMA-1 trial demonstrated clinical efficacy in patients with relapsed/refractory large B-cell lymphoma who were retreated with the CAR T-cell therapy axicabtagene ciloleucel.