On October 8, 2024 Verismo Therapeutics, a clinical-stage CAR-T company developing novel KIR-CAR platform technology, reported that it has activated its CELESTIAL-301 Phase 1 clinical trial at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) (Press release, Verismo Therapeutics, OCT 8, 2024, https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-the-activation-of-its-celestial-301-clinical-trial-at-colorado-blood-cancer-institute-302269554.html [SID1234647092]). CBCI offers clinical trials through SCRI, one of the world’s leading oncology research organizations conducting community-based clinical trials. CBCI is the largest and most experienced full-service blood and marrow transplant program in Colorado and among the top programs in the country, making it an ideal location for this clinical trial.
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CELESTIAL-301 will assess safety, tolerability, and preliminary efficacy of SynKIR-310 in patients with relapsed/refractory (r/r) B-cell Non-Hodgkin Lymphomas (B-cell NHL), including Diffuse Large B Cell lymphoma (DLBCL), Follicular Lymphoma (FL), Mantle Cell Lymphoma (MCL), and Marginal Zone Lymphoma (MZL). The Phase 1 multicenter clinical trial will enroll patients who previously received CAR T therapy but who have since relapsed or become refractory to it as well as patients who never received CAR T therapy.
CELESTIAL-301 trial seeks to address several areas of high unmet medical need. Commercially approved CAR T cell therapies have shown impressive high initial response rates in blood cancers. Over time, however, these therapies result in relapse in an estimated 40-50% of patients1. Such relapses are in part due to lack of long-term T cell effector function and persistence. There are currently very limited treatment options for patients with r/r DLBCL who relapse following treatment with commercial CAR T cell therapies. Ongoing clinical investigations into new and/or salvage therapies for these patients have not yet addressed the unmet medical need.
SynKIR-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR-310 is directed by DS191 to target a similar epitope of CD19 as the commercially approved CAR T therapies, with the added potential to prolong the anti-tumor T cell function and persistence. This could potentially improve KIR-CAR T Cell persistence and prevent early disease relapse in patients with aggressive lymphomas.
"This trial embodies Verismo’s continued commitment to combatting advanced cancers and addressing high areas of unmet medical need," said Dr. Laura Johnson, CSO of Verismo Therapeutics. "SynKIR-310 has significant potential to help patients with B-cell Non-Hodgkin Lymphomas and be especially beneficial for patients that relapsed after previous infusions of CAR T cell therapies."
Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter clinical trial investigating SynKIR-310. SynKIR-310 is Verismo’s second clinical pipeline following SynKIR-110, which targets aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-101 clinical trial, please visit ClinicalTrials.gov: NCT06544265.
About the KIR-CAR Platform
The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to regression of solid tumors and blood cancers in preclinical models that are resistant to traditional CAR T cell therapies. The KIR-CAR platform is being investigated in combination with many additional emerging technologies to potentially provide the next-generation multimodal targeted immunotherapy for patients in need.