B Cell LymphomaNHL, AdultMantle Cell LymphomaRelapsed Non-Hodgkin LymphomaRefractory Non-Hodgkin LymphomaAggressive B-Cell Non-Hodgkin LymphomaIndolent B-Cell Non-Hodgkin LymphomaFollicular LymphomaMarginal Zone LymphomaDLBCL - Diffuse Large B Cell LymphomaHGBL With MYC and BCL2 and/or BCL6 RearrangementsHigh-grade B-cell LymphomaDiffuse Large B Cell LymphomaLarge B-cell LymphomaT-Cell/Histiocyte Rich LymphomaNon-hodgkin Lymphoma,B CellPrimary Mediastinal Large B-cell Lymphoma (PMBCL)Epstein-Barr Virus Positive DLBCL, NosFollicular Lymphoma Grade 3BDLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic InflammationHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedFollicular Lymphoma Grade 3Marginal Zone Splenic LymphomaDLBCLWaldenstrom MacroglobulinemiaWaldenstrom Macroglobulinaemia
Investigational drug(s) / intervention(s)
SynKIR-310
SynKIR-310: Autologous T Cells transduced with CD19 KIR-CAR
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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 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 Criteria:
* 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
* 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.
* 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.
* Any active uncontrolled systemic fungal, bacterial or viral infection.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary outcome measure(s)
Evaluate the safety of SynKIR310 — Up to 24 months The incidence, frequency, and severity of adverse events (AEs), including serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and dose-limiting toxicities (DLTs).
Presence of RCL-VSV-G
Recommended Phase 2 Dose (RP2D) — Up to 24 months All available data from dose escalation cohorts will be evaluated to determine RP2D
Trial sites (5)
Facility
City
Region
Status
Colorado Blood Cancer Institute, part of Sarah Cannon Cancer Institute
Denver
Colorado
Recruiting
Winship Cancer Institute of Emory University
Atlanta
Georgia
Recruiting
The University of Kansas Cancer Center
Fairway
Kansas
Recruiting
Rutgers Cancer Institute
New Brunswick
New Jersey
Recruiting
Abramson Cancer Center of the University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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