FDA Places Clinical Hold on CD19-Specific CAR-T Phase 1 Trial

The FDA imposed a clinical hold on a Phase 1 trial to evaluate CD19-specific CAR-T therapies.

Sponsor Ziophram Oncology is seeking to conduct the trial to evaluate CAR-T cells manufactured with its “Sleeping Beauty” technology as a potential treatment for relapsed or refractory CD19+ leukemias and lymphomas. The agency is requesting additional information relative to chemistry, manufacturing and controls.

Ziopharm said the hold will likely not affect timelines for the company’s planned second-generation clinical trial at the National Cancer Institute.