On June 17, 2026 Hebecell reported that U.S. Food and Drug Administration (FDA) has completed review of IND #32893, allowing the Phase 1/1b clinical study evaluating ProtoNK (HC101) in adolescent and young adult patients with recurrent or refractory Ewing sarcoma to proceed in the United States.
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The milestone advances HC101 into clinical evaluation and represents an important step in the development of HebeCell’s stem cell-derived NK cell platform.
The study is sponsored by University Hospitals Cleveland Medical Center and will be led by Dr. Verania Huerta Urrutia, Pediatric Hematology/Oncology, Angie Fowler Adolescent & Young Adult Cancer Institute at UH Rainbow Babies & Children’s Hospital and Assistant Professor of Pediatrics at Case Western Reserve University School of Medicine. The Phase 1/1b study will evaluate the safety, tolerability, and exploratory efficacy of HC101 in adolescent and young adult patients with recurrent or refractory Ewing sarcoma.
HC101 is an allogeneic natural killer (NK) cell therapy derived from human pluripotent stem cells using HebeCell’s proprietary manufacturing platform. The program is designed to provide a scalable and renewable source of NK cells for clinical use and represents the company’s lead oncology product candidate.
"I am very happy for the recent FDA clearance of the IND application for HebeCell’s unique ProtoNK (HC101) cell therapy for relapsed/refractory Ewing sarcoma in the adolescent and young adult (AYA) population," said Dr. Verania Huerta Urrutia. "This milestone speaks to the great partnership and collaboration we have with HebeCell. We are working on opening this Phase 1 clinical trial in the upcoming months, and we are hopeful and excited to keep bringing new alternative therapies for our patients."
HebeCell leadership also highlighted the importance of the milestone and the company’s commitment to advancing ProtoNK into the clinic.
"Advancing HC101 into clinical evaluation is an important milestone for HebeCell and reflects years of work developing our stem cell-derived NK cell platform. We are excited to support the study and look forward to learning from this next phase of development," said Dr. Shi-Jiang Lu, Co-Founder and Chief Executive Officer of HebeCell.
(Press release, HebeCell, JUN 17, 2026, View Source [SID1234668776])