SynKIR-310 Cell Therapy Tested in Adults With Relapsed B-Cell Lymphoma
Tests SynKIR-310, modified T cells, in adults with returning or resistant lymphoma.
Plain-language title generated from the registry record
Registry title: SynKIR-310 for Relapsed/Refractory B-NHL
Key facts
- Where
- Atlanta, Denver, Fairway, New Brunswick, and Philadelphia, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- Winship Cancer Institute of Emory UniversityAtlanta, United StatesTaking people
- Colorado Blood Cancer Institute, part of Sarah Cannon Cancer InstituteDenver, United StatesTaking people
- The University of Kansas Cancer CenterFairway, United StatesTaking people
- Rutgers Cancer InstituteNew Brunswick, United StatesTaking people
- Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Verismo Therapeutics
- Trial code
- NCT06544265
- Record updated
- 14 April 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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 disease, and expectation to remain off immunosuppressive therapy through duration of trial; Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients; Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Exclusion: Previously treated with any investigational agent within 30 days prior to screening; Any previous or concurrent malignancy, with the following exceptions:; Adequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level < 1.0 may also be permitted; 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; Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry; 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; Any active uncontrolled systemic fungal, bacterial or viral infection; Note: Other protocol defined Inclusion/Exclusion criteria may apply.