The FDA has recently announced that they have put a clinical trial for relapsed or refractory T-cell lymphoma patients and cutaneous T-cell lymphoma patients on hold.
This trial was a Phase 1 study evaluating an investigative therapy for adults with the condition called LB1902. It was a multi center study led by Legend Biotech.
LB1901 is a gene edited chimeric antigen receptor (CAR) T-cell therapy. The therapy works to target a protein called CD4 which is located on the cancer cells. This therapy was first approved by the FDA for investigational use back in December of 2020.
What Caused The Hold
Legend Biotech has already been informed of the trial’s hold, but the FDA will issue an official letter on March 11th.
The hold was initiated after the very first patient who received a dose of the treatment faced low counts of CD4+ T-cells in the peripheral blood. After noting these results, the company immediately notified the FDA.
Thankfully, the individual who initiated this hold hasn’t experienced any serious AEs which are drug related. They will be continued to be monitored carefully, following protocols.
You can read more about this hold and what the next steps may be for this therapy here.
