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Clinical Trials in the USA / NCT05665062
Active, not recruiting Phase 1

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

NCT05665062 · tracked via the Priya Life Science USA tracker
Sponsor
Synthekine
Phase
Phase 1
Started
2023-04-23
Last updated
2026-07-10

Condition(s) studied

CLL/SLLNHLMantle Cell LymphomaFollicular LymphomaLarge B-cell LymphomaIndolent B-Cell Non-Hodgkin LymphomaDiffuse Large B Cell Lymphoma

Investigational drug(s) / intervention(s)

SYNCAR-001 →STK-009 →Cyclophosphamide →Fludarabine →

SYNCAR-001: SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb

STK-009: STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb

Cyclophosphamide: lymphodepletion

Fludarabine: lymphodepletion

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Selected Inclusion Criteria: 1. Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL) 2. Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology 3. 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: 1. Prior CD19 directed therapy including CD19 CARTs 2. Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment 3. Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment. 4. Presence of GVHD

Primary outcome measure(s)

  • Dose Limiting Toxicities (DLTs) — Up to 28 days post infusion (SYNCAR-001+STK-009)
    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
  • Adverse events — Up to 24 months post infusion (SYNCAR-001+STK-009)
    Assess the safety and tolerability of STK-009 in combination with SYNCAR-001 by review of AEs

Trial sites (4)

FacilityCityRegionStatus
City of Hope Duarte California
Roswell Park Buffalo New York
Memorial Sloan Kettering Cancer Center New York New York
Cleveland Clinic Cleveland Ohio

More Synthekine trials in the USA

Study of STK-012 Alone and With Other Treatments in Patients With Advanced Lung Cancer and Other Cancers Recruiting
A Phase 1 Study of SYNCAR-001 + STK-009 Without Conditioning Chemotherapy (Lymphodepletion) in Subjects With Severe, Refractory Systemic Autoimmune Rheumatic Disease Active, not recruiting

Other trials for the same condition

Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Active, not recruiting
A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL) Recruiting
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas Recruiting
Study of Rondecabtagene Autoleucel in Aggressive Large B-Cell Lymphoma Recruiting
A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05665062 on ClinicalTrials.gov ↗ ← All trials in the USA