Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
CLL/SLL, NHL, Mantle Cell Lymphoma
About this trial
This is an interventional treatment trial for CLL/SLL focused on measuring CART, CD19-CART, Chimeric antigen receptor, IL-2
Eligibility Criteria
Selected Inclusion Criteria: Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL) Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology No signs of symptoms of central nervous system (CNS) disease or detectable evidence of CNS or meningeal disease on magnetic resonance imaging (MRI) at the time of screening Selected Exclusion Criteria: Prior CD19 directed therapy including CD19 CARTs Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment. Presence of GVHD
Sites / Locations
- City of HopeRecruiting
- Roswell Park
- Columbia University Irving Medical CenterRecruiting
- Memorial Sloan Kettering Cancer Center
- Cleveland ClinicRecruiting
Arms of the Study
Arm 1
Experimental
SYNCAR-001 + STK-009
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose extension: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D