SynKIR-310 for Relapsed/Refractory B-NHL

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.
• Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014).
• 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.
• 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.
• 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.
• Known immunodeficiency disease.
• 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.