About this trial

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.

Eligibility criteria

Qualifiers

Adult 18 years of age and older.

Histologically confirmed diagnosis of B-NHL before enrollment.

Must have received prior CAR T or were unwilling/unable to receive prior CAR T.

Must have refractory or relapsed disease after receiving 2 prior lines of therapies.

Disqualifiers

Previously treated with any investigational agent within 30 days prior to screening.

Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis

Known immunodeficiency disease , with the exception of hypoglobulinemia

History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia/hemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.

Trial design

Treatments tested in this trial

  • SynKIR-310

Treatment groups

36 Participants
are divided into 1 treatment group

Locations

5
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute80218, DenverColorado, United States
Winship Cancer Institute of Emory University30322, AtlantaGeorgia, United States
The University of Kansas Cancer Center66205, FairwayKansas, United States
Rutgers Cancer Institute08902, New BrunswickNew Jersey, United States

Sponsors and collaborators

Verismo Therapeutics

Lead sponsor