SynKIR-310 for Relapsed/Refractory B-NHL

Active:	Yes
Cancer Type:		NCT ID:	NCT06544265
Trial Phases:	Phase I	Protocol IDs:	CELESTIAL-301 (primary) NCI-2025-03031
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Verismo Therapeutics
NCI Full Details:	http://clinicaltrials.gov/show/NCT06544265

Summary

This first-in-human (FIH) trial is designed to assess the safety, feasibility and
preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to
participants with relapsed/refractory B-NHL.

Objectives

This is a Phase 1, FIH, multicenter, open-label study of a single infusion of SynKIR-310
in participants with relapsed/refractory B-NHL.

Up to 18 participants, regardless of subtypes of B-NHL, who meet the eligibility
criteria, will be treated in the study.

2 cohorts of 3 to 6 participants per cohort will be assessed to determine the safety and
feasibility of treatment with SynKIR-310. Doses will be escalated across 2 cohorts to
determine a Recommended Phase 2 Dose (RP2D).

Once the RP2D has been determined, a dose expansion group will enroll additional
participants regardless of subtypes of B-NHL at the RP2D to further characterize the
safety, feasibility and preliminary efficacy of SynKIR-310 in treating B-NHL.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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