NCT06544265 SynKIR-310 for Relapsed/Refractory B-NHL

Eligibility & Interventions

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 36 participants in total. It began in 2024-11-01 with a primary completion date of 2028-09.

Brief 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 Criteria

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.

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