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

The goal of this Phase 1/2a interventional study is to evaluate the safety and tolerability of CRG-150 in relapsed/refractory HR+HER2- breast cancer, Triple Negative Breast Cancer (TNBC) and prostate cancer. The main questions it aims to answer are: Phase 1 * Incidence of DLTs * Incidence of CRG-150 related AEs and SAEs * Select the Recommended Phase 2 Dose (RP2D), as determined through the dose escalation process for the specified indications Phase 2a * HR+HER2- Breast Cancer and TNBC: Overall Response Rate (ORR) (CR+PR) using FDG PET/CT and RECIST 1.1 by Investigator assessment * Prostate Cancer: ORR per PCWG3-modified RECIST 1.1 by Investigator assessment Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: • CRG-150 cells at the assigned dose

NCT Number	NCT07730125
Lead Sponsor	CoRegen, Inc. Collaborators: Baylor College of Medicine
Conditions	HR-positive, HER2-negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Prostate Cancer
Enrollment	67 participants
Start Date	2026-11
Primary Completion	2029-06 (estimated)
Study Completion	2030-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-07