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
Locations
5Sponsors and collaborators
Verismo Therapeutics
Lead sponsor