Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19… (NCT05665062) | Clinical Trial Compass
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on measuring dose-limiting toxicities and adverse events — what does that mean for what's still unknown about the safety of this specific combination of SYNCAR-001 and STK-009, and how does that affect whether it might be right for me?
2I see the trial is no longer actively recruiting — is there any chance I could still be considered for enrollment, or are there other similar CAR-T cell therapy trials I should be looking into instead?
3CAR-T cell therapies can involve serious side effects like cytokine release syndrome — how does adding an orthogonal IL-2 like STK-009 potentially change the risk profile compared to standard CAR-T approaches I might already be eligible for?
4Since this trial is for several different CD19-positive blood cancers including my specific diagnosis, would my particular disease type or treatment history affect how relevant this trial's early safety data might be for me?
5Given that this is still an early-phase study, is there a standard treatment option I should consider first, and under what circumstances would it make more sense to explore this trial rather than starting with an established therapy?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days post infusion (SYNCAR-001+STK-009)
2
Adverse events
Timeframe: Up to 24 months post infusion (SYNCAR-001+STK-009)