Gene-edited T Regulatory Cells (CRG-150) for the Treatment of Relapsed/Refractory Malignancies

This is a first-in-human, open-label, multicenter Phase 1/2a study of CRG-150, an autologous gene-edited Treg cell therapy that will follow a BOIN design of dose-escalating cohorts to determine a Recommended Phase 2 Dose (RP2D). Phase 2a participants will be treated with CRG-150 at the determined RP2D. Following consent and screening assessments, enrolled participants will undergo an apheresis procedure to manufacture the autologous product. The time from apheresis to delivery of product back to the patient is anticipated to be approximately 28 days, and bridging therapy will be allowed between apheresis and CRG-150 infusion at the Investigator's discretion. No lymphodepleting chemotherapy will be administered prior to CRG-150 infusion. Participants are followed for disease outcomes for 12 months and for long-term safety for up to 15 years, consistent with FDA guidance.