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Recruiting
NCT05665062
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
Conditions: CLL/SLL, NHL, Mantle Cell Lymphoma, Follicular Lymphoma, Large B-cell Lymphoma, Indolent B-Cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 36
Sponsor: Synthekine
Location: United States
Summary
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
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 histologyNo 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 screeningSelected Exclusion Criteria:Prior CD19 directed therapy including CD19 CARTsPrior allogeneic hematopoietic stem cell transplant within 6 months of enrollmentPrior autologous hematopoietic stem cell transplant within 6 weeks of enrollment.Presence of GVHD
Source: ClinicalTrials.gov (NCT05665062). StuddyBuddy aggregates publicly available trial information.
