On January 10, 2025 Verismo Therapeutics, a clinical-stage CAR T company developing novel KIR-CAR platform technology, reported that it has dosed the first patient in its CELESTIAL-301 Phase 1 clinical trial (Press release, Verismo Therapeutics, JAN 10, 2025, View Source [SID1234649610]). The patient was infused at Sarah Cannon Research Institute (SCRI) at Colorado Blood Cancer Institute (CBCI) in Denver, Colorado.

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CELESTIAL-301 aims to 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 is enrolling 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 due in part 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.

SynKIR-310 relies on Verismo’s unique KIR-CAR platform and proprietary CD19 binder (DS191). SynKIR-310 targets CD19, similarly to the commercially approved CAR T therapies, with the added potential of prolonged anti-tumor T cell function and persistence. These KIR-CAR improvements may prevent early disease relapse in patients with advanced B cell lymphomas.

"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. CBCI’s commitment to patients and to conducting novel early-stage clinical trials has allowed us to reach this milestone earlier than expected," according to Dr. Laura Johnson, Chief Operations Officer and Chief Scientific Officer at Verismo Therapeutics. "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."

"We are thrilled to administer this promising therapy," said Michael Tees, MD, the principal investigator at SCRI at Colorado Blood Cancer Institute (CBCI), where the first patient was dosed. "Emerging treatments like SynKIR-310 have potential to reshape care for patients with advanced lymphomas, offering new hope. This milestone showcases the impact of CBCI and other expert research centers in advancing early-stage clinical trials."

Verismo achieved IND clearance from the FDA in May 2024 to proceed with this multicenter Phase 1 clinical trial investigating SynKIR-310. SynKIR-310 is Verismo’s second clinical pipeline following SynKIR-110 targeting aggressive mesothelin-expressing solid tumors. For more information about the CELESTIAL-301 clinical trial, please visit ClinicalTrials.gov: NCT06544265.