On October 2, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported that it has treated the first patient with follicular lymphoma (FL) in its CELESTIAL-301 Phase 1 clinical trial of SynKIR-310 (Press release, Verismo Therapeutics, OCT 2, 2025, View Source [SID1234656412]). This milestone reflects Verismo’s commitment to addressing the urgent unmet medical need for patients with FL and further strengthens the company’s collaboration with the Institute for Follicular Lymphoma Innovation (IFLI).
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CELESTIAL-301 is a multicenter Phase 1 trial (NCT06544265) evaluating the safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory B cell non-Hodgkin lymphomas (B-NHL), including FL. The study is enrolling both patients who have relapsed after prior CAR T therapy as well as those who never received CAR T treatment.
SynKIR-310 combines Verismo’s proprietary KIR-CAR platform with a new CD19 binder, which was developed by the University of Pennsylvania (Penn) under a sponsored research agreement between Penn and Verismo and exclusively licensed to Verismo, to target malignant B cells. Preclinical studies indicated that the KIR-CAR technology may extend T cell persistence, offering the potential to reduce relapse rates. The trial design includes 2 cohorts with dose escalation and an expansion cohort at the recommended Phase 2 dose.
"Treatment of the first FL patient in CELESTIAL-301 is an important milestone in the development of a CD19-directed KIR-CAR therapy and underscores the strength of our relationship with IFLI," said Dr. Bryan Kim, co-founder and CEO of Verismo Therapeutics. "We appreciate IFLI’s commitment and expertise, which are helping us advance SynKIR-310 for individuals in urgent need of new options."
In January 2025, Verismo announced a strategic investment from IFLI of up to $4.05 million to support the SynKIR-310 FL program, enabling expanded FL-focused clinical sites to increase FL patient enrollment.
"Treating the first FL patient in CELESTIAL-301 is an important step toward delivering next-generation cell therapies to this underserved patient population," said Michel Azoulay, MD, MBA, Chief Medical Officer of IFLI. "We are proud to work with Verismo to accelerate the development of SynKIR-310 for follicular lymphoma."