Verismo Therapeutics’ Trial for CAR-T SynKIR-310 Doses First Patient With Follicular Lymphoma

The first patient with follicular lymphoma (FL) has been dosed in Verismo Therapeutics’ phase 1 CELESTIAL-301 clinical trial (NCT06544265), which is evaluating SynKIR-310, a chimeric antigen receptor T-cell (CAR-T) therapy based on the company's killer immunoglobulin-like receptor (KIR)-CAR platform, in patients with various types of relapsed/refractory (r/r) B-cell nonHodgkin lymphoma (B-NHL).¹

Verismo emphasized that the milestone strengthens its relationship with the Institute for Follicular Lymphoma Innovation, which made an “up to $4.05 million strategic investment” in the program earlier this year with the intent of expanding FL-focused trial sites.¹ Notably, CELESTIAL-301 is open to both patients whose disease has previously relapsed after a CAR-T treatment and those who have not previously received CAR-T.

"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," Bryan Kim, DMD, the cofounder and chief executive officer of Verismo, said in a statement.¹ "We appreciate IFLI's commitment and expertise, which are helping us advanceSynKIR-310 for individuals in urgent need of new options."

The dosing of the first patient overall to be treated in CELESTIAL-301 was announced by Verismo in January 2025 and took place in Denver, Colorado at the Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI).² In addition to FL, the multicenter study is open to patients with forms of r/r B-NHL including diffuse large B-cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma, but Verismo did not specify the diagnosis of the first patient to be treated in the January announcement.

SynKIR-310 is based on Verismo’s KIR-CAR platform, which was developed at the University of Pennsylvania, and is intended to enable sustained antitumor activity of the CAR T-cells in difficult tumor microenvironments.³ KIR-CAR is a dual-chain CAR T-cell platform that uses a natural killer cell derived KIR and DAP12, which acts as a novel costimulatory molecule for T-cells, to improve expression and persistence.^2,3

"The initiation of patient dosing in the CELESTIAL-301 trial marks an exciting milestone for Verismo Therapeutics as we advance our mission to develop transformative therapies for patients facing advanced lymphomas,” Laura Johnson, PhD, the chief operations officer and chief scientific officer at Verismo, said in a statement at the time.² “CBCI's commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected. SynKIR-310 is uniquely designed to prolong T-cell functional persistence and combat the challenges of disease relapse, offering a potentially life-saving option for these patients."

SynKIR-310 is not the only CAR-T product currently in development for FL.⁴ Earlier this year, a poster presented at the European Hematology Association (EHA) 2025 Congress, held June 12 to 15, both virtually and in Milan, Italy, by Katsiaryna Zharkova, of N. N. Alexandrov National Cancer Centre of Belarus, showed that an academic CD19-directed CAR-T therapy produced an 86.7% (13 patients) objective response rate (ORR) in a study of 15 patients with FL.⁴ Out of the 13 patients who responded to the CAR-T product, 11 patients (73.4%) achieved a complete response (CR) and 2 patients (13.3%) achieved a partial response. The 2 patients who did not achieve a response (13.3%) experienced disease progression.

“Academic antiCD19 CAR-T cell therapy has demonstrated efficacy and safety in patients with r/r FL, including its use in second line therapy in high-risk patients,” Zharkova and colleagues concluded.⁴

REFERENCES
1. Verismo Therapeutics treats first follicular lymphoma patient in CELESTIAL-301 trial, strengthening collaboration with IFLI. News release. Verismo Therapeutics. October 2, 2025. Accessed October 10, 2025.https://www.prnewswire.com/news-releases/verismo-therapeutics-treats-first-follicular-lymphoma-patient-in-celestial-301-trial-strengthening-collaboration-with-ifli-302573330.html?tc=eml_cleartime
2. Verismo Therapeutics announces first patient infused in phase 1 CELESTIAL-301 clinical trial of SynKIR™-310. News release. Verismo Therapeutics. January 10, 2025. Accessed January 13, 2025. https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-first-patient-infused-in-phase-1-celestial-301-clinical-trial-of-synkir-310-302347464.html?tc=eml_cleartime
3. Verismo Therapeutics announces the activation of its STAR-101 clinical trial at the University of Pennsylvania. News release. Verismo Therapeutics. May 2, 2023. Accessed January 13, 2025. https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-the-activation-of-its-star-101-clinical-trial-at-the-university-of-pennsylvania-301812763.html?tc=eml_cleartime
4. Zharkova K, Konoplya N, Kalenik V, et al. Efficacy and safety of academic anti-CD19 CAR-T cell therapy for relapsed/refractory follicular lymphoma. Presented at: EHA 2025 Congress, June 12-15, virtual and in Milan, Italy. Abstract #PF912