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NCT Number: NCT05665062

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

CLL/SLL Diffuse Large B Cell Lymphoma Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Indolent B-Cell Non-Hodgkin Lymphoma Large B-cell Lymphoma Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma NHL Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

City of Hope, Duarte, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYNCAR-001

Drug

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

STK-009

Drug

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

Cyclophosphamide

Drug

lymphodepletion

Fludarabine

Drug

lymphodepletion

Primary outcomes

  1. Dose Limiting Toxicities (DLTs)

    Time frame: 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

  2. Adverse events

    Time frame: 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

Secondary outcomes

  1. Objective response rate (ORR)

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

    The ORR to treatment with SYNCAR-001 + STK-009

  2. Duration of Response (DOR)

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

    To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration.

  3. Progression Free Survival (PFS)

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

    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.

  4. Area under the curve (AUC)

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

    The quantification of the cumulative amount of drug over time.

  5. Maximum Concentration (Cmax)

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

    To identify the maximum (peak) drug concentration dosing.

  6. Time of maximum concentration

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

    The time to reach maximum (peak) drug concentration after dosing.

  7. Immunogenicity

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

    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)

Sponsors and collaborators

Lead sponsor

Synthekine

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2041
First posted
Dec 27, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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