July 07, 2026 —
The U.S. Food and Drug Administration has cleared CoRegen’s Investigational New Drug application for CRG-150, allowing the company to begin a first-in-human Phase 1/2a clinical trial of its autologous CRISPR-engineered regulatory T cell therapy in patients with advanced solid tumors.
The study will evaluate safety and preliminary efficacy in metastatic triple-negative breast cancer, metastatic HR-positive/HER2-negative breast cancer, and metastatic prostate cancer at leading academic cancer centers.
CRG-150 represents a differentiated approach to engineered cell therapy. Rather than modifying cytotoxic immune cells to directly recognize and kill tumor cells, the therapy uses CRISPR gene editing to reprogram regulatory T cells, or Tregs, with the goal of reversing immune suppression in the tumor microenvironment and restoring endogenous antitumor immunity.
The approach is based on more than three decades of research at Baylor College of Medicine on steroid receptor coactivator-3, or SRC-3, a transcriptional regulator positioned upstream of multiple immune signaling pathways. CoRegen’s strategy uses CRISPR-mediated disruption of SRC-3 to alter Treg biology and remove one of the mechanisms tumors use to evade immune surveillance.
In preclinical studies across multiple murine solid tumor models, CoRegen reported that SRC-3-disrupted Tregs produced durable tumor eradication. When animals were later rechallenged with the original tumor, researchers observed rapid elimination consistent with immunologic memory. Additional experiments suggested antitumor responses could extend across different tumor types, although these findings remain to be validated in humans.
Tregs normally play an essential role in immune tolerance by preventing excessive immune activation and autoimmunity. In cancer, however, many tumors recruit or expand Tregs within the tumor microenvironment, where they suppress cytotoxic T cells and natural killer cells. This can limit endogenous antitumor immunity and contribute to resistance to immunotherapy.
CRG-150 is designed to change that biology. The therapy begins with collection of a patient’s peripheral blood cells. Tregs are isolated, edited ex vivo using CRISPR to disrupt SRC-3, expanded, and reinfused into the patient. Because the product is autologous, the cells come from the same patient and may already reflect exposure to tumor antigens.
A notable feature of the program is that patients are not expected to require lymphodepleting chemotherapy before receiving treatment. This differentiates CRG-150 from many CAR-T approaches, which typically require lymphodepletion and are associated with additional treatment burden and toxicity.
The Phase 1/2a trial will use a dose-escalation and cohort-expansion design. Phase 1 will focus on safety and identification of the recommended Phase 2 dose, followed by expansion cohorts to evaluate preliminary efficacy in the selected metastatic solid tumor indications.
CoRegen has partnered with Lonza under a multi-year manufacturing agreement to support clinical production. The company said manufacturing consistency was an important component of the IND package reviewed by the FDA.
The IND clearance places CoRegen within a rapidly evolving field of engineered immune cell therapies. While most Treg programs are being developed for autoimmune disease, inflammatory disorders, and transplantation, CRG-150 applies Treg engineering to oncology by attempting to reprogram immune suppression rather than directly attack tumor cells through antigen targeting.
If the approach translates clinically, CRG-150 could open a new therapeutic category in solid tumor immunotherapy by using engineered Tregs to remodel the tumor microenvironment and enable the patient’s own immune system to mount a broader antitumor response.
