Clinical Research Directory

Inclusion Criteria: 1. Signed ICF 2. Male or female patients who are 12 years of age and above 3. Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy 4. At least 1 lesion, which must be fluordeoxyglucose positron emission tomography (FDG-PET) avid and measurable by PET-CT scan 5. Adequate laboratory parameters including hematologic, renal, hepatic, and coagulation function 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, or equivalent either Karnofsky performance status (for patients ≥ 16 years of age) or Lansky performance status (for patients \< 16 years of age) 7. Anticipated life expectancy \> 12 weeks 8. No active infections including COVID 19 at Screening Exclusion Criteria: 1. Evidence of lymphomatous involvement of the central nervous system (CNS) 2. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement 3. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification 4. Active uncontrolled bleeding or a known bleeding diathesis 5. Inadequate pulmonary function defined as oxygen saturation by pulse oximetry \< 90% on room air 6. Echocardiogram (ECHO) or Multi-gated Acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) \< 45% 7. Prior receipt of salvage therapy, for relapsed or refractory cHL, including allogeneic or ASCT 8. Prior receipt of investigational CD30.CAR-T cells 9. Receiving any investigational agents or any tumor vaccines 10. Receiving any live/attenuated vaccines 11. Ongoing treatment with immunosuppressive drugs or chronic systemic corticosteroids 12. Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments 13. Previous history of known or suspected autoimmune disease within the past 5 years 14. Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity 15. Evidence of human immunodeficiency virus (HIV) infection 16. Evidence of active viral infection with hepatitis B virus (HBV) 17. Evidence of active viral infection with hepatitis C virus (HCV) 18. Active second malignancy or history of another malignancy within the last 3 years 19. History of hypersensitivity reactions to murine protein-containing products or other product excipients 20. Any allergic or adverse reaction to nivolumab, fludarabine, or bendamustine that precludes treatment with these agents 21. History of a significant irAE from prior immune checkpoint inhibitor therapy