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

April 2, 2025 updated by: Synthekine

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SYNCAR-001 + STK-009 Cohort A

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
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
Drug: STK-009
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
Drug: Cyclophosphamide
lymphodepletion
Drug: Fludarabine
lymphodepletion
Experimental: SYNCAR-001 + STK-009 Cohort B

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
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
Drug: STK-009
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days post infusion (SYNCAR-001+STK-009)
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
Up to 24 months post infusion (SYNCAR-001+STK-009)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months post infusion (SYNCAR-001+STK-009)
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.
Up to 24 months post infusion (SYNCAR-001+STK-009)
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.
Up to 24 months post infusion (SYNCAR-001+STK-009)
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.
Up to 24 months post infusion (SYNCAR-001+STK-009)
Maximum Concentration (Cmax)
Time Frame: Up to 24 months post infusion (SYNCAR-001+STK-009)
To identify the maximum (peak) drug concentration dosing.
Up to 24 months post infusion (SYNCAR-001+STK-009)
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.
Up to 24 months post infusion (SYNCAR-001+STK-009)
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)
Up to 24 months post infusion (SYNCAR-001+STK-009)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthekine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 23, 2023

Primary Completion (Estimated)

June 24, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STK-009-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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