Cell Therapy News

The FDA cleared an investigational new drug application for FT536, a chimeric antigen receptor natural killer cell therapy designed to treat adults with certain relapsed or refractory solid tumors.

An enhanced lymphodepletion regimen followed by chimeric antigen receptor T-cell therapy induced response among patients with relapsed or refractory B-cell malignancies, according to results presented at ASH Annual Meeting and Exposition.

The FDA lifted its clinical hold on a series of trials that use Allogene Therapeutics’ AlloCAR T chimeric antigen receptor T-cell therapies, according to a press release from the manufacturer.

Younger Hispanic/Latinx patients face many barriers that may limit timely access to chimeric antigen receptor T-cell therapy trials for relapsed or refractory B-cell acute lymphoblastic leukemia, according to retrospective study results.

A chimeric antigen receptor T-cell therapy induced high response rates across a range of B-cell malignancies, according to phase 1 study results presented at ASH Annual Meeting and Exposition.

The FDA granted fast track designation to LioCyx-M004, a T-cell receptor T-cell therapy for treatment of adults with hepatitis B virus-related hepatocellular carcinoma.

The FDA granted fast track designation to CYNK-001 for the treatment of adults with relapsed or refractory acute myeloid leukemia.

The FDA cleared an investigational new drug application for P-MUC1C-ALLO1, a chimeric antigen receptor T-cell therapy designed to treat adults with locally advanced or metastatic epithelial-derived solid tumors.

The FDA granted orphan drug designation to NKX101 for treatment of acute myeloid leukemia.

Early clinical trials for the first chimeric antigen receptor T-cell therapies mandated recipients receive rigorous post-treatment monitoring, often requiring inpatient admittance lasting anywhere from 2 to 4 weeks.