Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
Non-hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Non-hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria: Target population must have relapsed, progressive or refractory non-hodgkin lymphoma and be ineligible for or have exhausted standard therapeutic options that may prolong survival The subject must have fluoro-deoxyglucose (FDG)-avid lymphoma with measurable disease CD38 positive tumor at most recent biopsy (new or archival) documented at central laboratory Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for the trial and is willing to participate in the trial. Exclusion Criteria: Primary central nervous system lymphoma or known central nervous system involvement with lymphoma Systemic chemotherapy, radiotherapy, immunotherapy, or major surgery administered within 3 weeks (for nitrosoureas within 6 weeks) prior to the first dose of CD38-SADA Radioimmunotherapy within 100 days prior to the first dose of CD38-SADA Autologous stem cell transplantation within 42 days prior to the first dose of CD38-SADA Treatment with approved CAR-T within 100 days prior to the first dose of CD38-SADA >40% lymphoma bone marrow involvement
Sites / Locations
Arms of the Study
Arm 1
Experimental
CD38-SADA:177Lu-DOTA Complex