Multicenter, open-label study will evaluate the safety and preliminary efficacy of CK0802, a first-in-class, off-the-shelf Treg therapy, in patients with steroid-refractory GVHD

Cellenkos^®, Inc., a clinical stage biotechnology company, pioneering allogeneic, tissue-targeted regulatory T cell (Treg) therapies, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application to initiate a Phase 1b/ 2a clinical trial of CK0802 for the treatment of patients with steroid-refractory graft-versus-host disease (GVHD).

Steroid-refractory GVHD represents a critical unmet need in post-transplant care. While allogeneic stem cell transplants are curative for many blood cancers, the procedure carries the risk of GVHD—a condition where donor cytotoxic T cells "misfire," recognizing the patient's healthy organs as foreign and launching a systemic attack. This typically manifests as severe skin rashes, debilitating diarrhea, and liver failure.

Current first-line treatment relies on high-dose intravenous steroids. However, steroids act as a "blunt instrument," suppressing the aggressive T cells while simultaneously depleting the healthy immune system, leaving patients vulnerable to life-threatening infections. In nearly 50% of cases, steroids fail to calm the immune attack. Currently available second-line therapies often struggle to provide lasting results, frequently hampered by severe immunosuppression and hematologic toxicities. Due to these limitations, patients face a poor prognosis, with two-year survival rates currently stagnating at approximately 30%. Novel therapies are urgently needed.

"FDA clearance to advance CK0802 into a Phase 1b/ 2a trial marks a hopeful step forward for patients facing the dire prognosis of steroid-refractory GVHD," said Simrit Parmar, MD, MSCI, Founder of Cellenkos, and Faculty, Texas A&M, School of Engineering and Medicine (EnMed). "CK0802 is uniquely qualified to function under intense inflammatory stress, resetting the patient's immune system, and de-escalating donor T-cell attack without the toxicities typically associated with broad-spectrum immunosuppression."