A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Verismo Therapeutics
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.
Description
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 36 participants, regardless of subtypes of B-NHL, who meet the eligibility criteria, will be treated in the study. Up to 4 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 up to 4 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. * If relapsed/refractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment. * If relapsed/refractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host d…
Interventions
- BiologicalSynKIR-310
Autologous T Cells transduced with CD19 KIR-CAR
Locations (5)
- Colorado Blood Cancer Institute, part of Sarah Cannon Cancer InstituteDenver, Colorado
- Winship Cancer Institute of Emory UniversityAtlanta, Georgia
- The University of Kansas Cancer CenterFairway, Kansas
- Rutgers Cancer InstituteNew Brunswick, New Jersey
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania