All of Allogene Therapeutics’ clinical trials are now under an FDA clinical hold. The halt was handed down after one patient in the company’s most advanced study developed what the company described as a “chromosomal abnormality.”
Data on multiple CAR-Ts presented at the recent ASCO meeting have raised the prospect of outpatient use of the therapies, which is favorable for reimbursement as well as for patients. But experts pointed to significant infrastructure challenges that centers face.
The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes.
While cautioning that it's still early days, experts said the data - especially those showing much lower toxicity - raise the prospect that the therapy could replace autologous CAR-Ts, if its efficacy remains the same.
The Phase I study is planned to enroll 24 patients with relapsed/refractory diffuse large B-cell lymphoma and follicular lymphoma and will be run under Allogene's collaboration with Servier.
The filing comes one week after the company, founded earlier this year with a $300 million Series A round by two former Kite executives, raised $120 million in a private financing.