This first-in-human Phase 1 study tests SYNCAR-001, an autologous CD19 CAR-T cell therapy, together with STK-009, an orthogonal IL-2, with cyclophosphamide and fludarabine, in patients with CD19-positive hematologic malignancies. Participants must have histologically confirmed relapsed/refractory hematologic malignancies, including CLL/SLL and selected non-Hodgkin lymphomas (NHL), documented or highly likely CD19 expression, and no signs of central nervous system disease.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Selected Inclusion Criteria: 1. Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL) 2. Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology 3. 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: 1. Prior CD19 directed therapy including CD19 CARTs 2. Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment 3. Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment. 4. Presence of GVHD