Dr Chahoud on the Safety of ALLO-316 in Advanced ccRCC

“We didn’t see…grade 3 CRS [effects], which was great. We [also] didn’t see any GVHD, which is great for patients receiving an allogeneic CAR T-cell therapy.”

Jad Chahoud, MD, MPH, an associate member of the Department of Genitourinary Oncology and medical director of IPOP at Moffitt Cancer Center, discussed safety data with the off-the-shelf, HLA-unmatched, CD70-directed CAR T-cell therapy ALLO-316 for the treatment of patients with advanced clear cell renal carcinoma (ccRCC).

During the 2025 ASCO Annual Meeting, investigators presented data from the phase 1 TRAVERSE study (NCT04696731), which evaluated the safety profile of ALLO-316 in patients with CD70-positive ccRCC who had received prior PD-1 axis– and VEGF-targeted therapies.

Findings from TRAVERSE revealed that no patients experienced grade 3 or higher cytokine release syndrome (CRS), Chahoud said. All CRS events were limited to grade 1 or 2 in severity. Notably, no cases of graft-vs-host disease (GVHD) were observed, he added, underscoring the tolerability of allogeneic CAR T-cell therapy in this population.

A more clinically significant toxicity was immune effector cell–associated hemophagocytic lymphohistiocytosis (IEC-HS), Chahoud explained. Two patients experienced grade 3 or higher IEC-HS–like events, though none were fatal, he said. Importantly, a structured management approach was developed to address this complication, which allowed most patients to continue treatment successfully, according to Chahoud.

Additional treatment-emergent adverse effects included fatigue, loss of appetite, and nausea, which were generally manageable, he noted. Grade 3 or higher hematologic included neutropenia and thrombocytopenia. Interstitial lung disease (ILD) occurred in a small proportion of patients, with approximately 2 experiencing grade 3 ILD that required treatment discontinuation, he added.

Chahoud emphasized that no treatment-related deaths occurred in the study, and no new safety signals were identified. He concluded that ALLO-316 was associated with a manageable safety profile characterized by low-grade CRS, the absence of GVHD, and isolated cases of IEC-HS, which can be effectively addressed through proactive management strategies.