Active — Not RecruitingPhase 1

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

United States36 participantsStarted 2023-04-23

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days post infusion (SYNCAR-001+STK-009)

Adverse events

Timeframe: Up to 24 months post infusion (SYNCAR-001+STK-009)

NCT IDNCT05665062

SponsorSynthekine

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-24