NCT05665062Active, not recruitingPhase 1
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
A Phase 1 Study to Evaluate the Safety and Tolerability of a Combination Autologous CD19 CAR T Cell Therapy (SYNCAR-001 + STK-009) in Subjects With Relapsed or Refractory CD19+ Hematologic Malignancies
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 8 Dec 2022
- Start date
- 23 Apr 2023
- Primary completion date
- 24 Jun 2028
- Lead sponsor
- Synthekine
- NCT number
- NCT05665062
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 23 Apr 2023 to the primary completion date, 24 Jun 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Roswell Park Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.