Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

Status: closed to accrual

This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

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

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

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell

therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell

(CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an

engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. The study will follow a

3+3 design during dose escalation. Cohort A will enroll subjects to SYNCAR-001 + STK-009

with lymphodepletion. At Dose Level 3, a separate dose escalation cohort will be

introduced to enroll subjects to SYNCAR-001 + STK-009 without lymphodepletion (Cohort B).

Subsequent dose expansions will enroll subjects at the RP2D for each cohort.

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