A Phase 1 interventional study of SYNCAR-001 and STK-009 in CLL/SLL, NHL and Mantle Cell Lymphoma, sponsored by Synthekine. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Synthekine · Phase 1, Interventional, and Treatment
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
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.
783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.
This study's planned enrollment of 36 is close to the median of 39 across 699 interventional studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →Synthekine is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Selected Inclusion Criteria:
Selected Exclusion Criteria:
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D
Drug: SYNCAR-001 · Drug: STK-009 · Drug: Cyclophosphamide · Drug: Fludarabine
Dose escalation: A single fixed dose of autologous SYNCAR-001 CAR-T intravenously (IV) will be administered in combination with repeated sequential ascending doses of STK-009 subcutaneously (SC) Dose expansion: A single fixed dose of autologous SYNCAR-001 CAR-T IV will be administered in combination with repeated doses of STK-009 SC at the RP2D
Drug: SYNCAR-001 · Drug: STK-009
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
lymphodepletion
lymphodepletion
Dose Limiting Toxicities (DLTs)
Incidence of adverse events (AEs) meeting protocol defined DLT criteria and determination of the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of STK-009 in combination with a fixed dose of SYNCAR-001
Time frame: Up to 28 days post infusion (SYNCAR-001+STK-009)
Adverse events
Assess the safety and tolerability of STK-009 in combination with SYNCAR-001 by review of AEs
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Objective response rate (ORR)
The ORR to treatment with SYNCAR-001 + STK-009
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Duration of Response (DOR)
To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration.
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Progression Free Survival (PFS)
The time from the SYNCAR-001 administration date to the date of disease progression per Lugano Classification or iwCLL or death from any cause, whichever occurs earlier.
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Area under the curve (AUC)
The quantification of the cumulative amount of drug over time.
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Maximum Concentration (Cmax)
To identify the maximum (peak) drug concentration dosing.
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Time of maximum concentration
The time to reach maximum (peak) drug concentration after dosing.
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Immunogenicity
Immunogenicity will be assessed by summarizing the number of patients who develop detectable anti-STK-009 and/or anti-SYNCAR-001 anti-drug antibodies (ADAs)
Time frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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