synkir-310 for relapsed/refractory b-nhl

Conditions: B Cell Lymphoma; NHL, Adult; Mantle Cell Lymphoma; Relapsed Non-Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma; Aggressive B-Cell Non-Hodgkin Lymphoma; Indolent B-Cell Non-Hodgkin Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma; DLBCL - Diffuse Large B Cell Lymphoma; HGBL With MYC and BCL2 and/or BCL6 Rearrangements; High-grade B-cell Lymphoma; Diffuse Large B Cell Lymphoma; Large B-cell Lymphoma; T-Cell/Histiocyte Rich Lymphoma; Non-hodgkin Lymphoma,B Cell; Primary Mediastinal Large B-cell Lymphoma (PMBCL); Epstein-Barr Virus Positive DLBCL, Nos; Follicular Lymphoma Grade 3B; DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation; High Grade B-Cell Lymphoma, Not Otherwise Specified; Follicular Lymphoma Grade 3; Marginal Zone Splenic Lymphoma; DLBCL

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.

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 18 participants, regardless of subtypes of b-nhl, who meet the eligibility criteria, will be treated in the study. 2 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 2 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 subtypes of b-nhl at the rp2d to further characterize the safety, feasibility and preliminary efficacy of synkir-310 in treating 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. * 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.