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

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ClinicalTrials.gov Identifier: NCT05665062
Recruitment Status : Recruiting
First Posted : December 27, 2022
Last Update Posted : March 21, 2024
Sponsor:
Information provided by (Responsible Party):
Synthekine

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

Condition or disease Intervention/treatment Phase
CLL/SLL NHL Mantle Cell Lymphoma Follicular Lymphoma Large B-cell Lymphoma Indolent B-Cell Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Drug: SYNCAR-001 Drug: STK-009 Drug: Cyclophosphamide Drug: Fludarabine Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 24, 2022
Estimated Primary Completion Date : June 24, 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05665062


Contacts
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Contact: Clinical Operations 650.271.9888 clinicaltrialinfo@synthekine.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Michael Mei, MD    626-218-1133      
United States, New York
Roswell Park Recruiting
Buffalo, New York, United States, 14263
Contact: Megan Hughes    716-845-1300 ext 7298    megan.hughes@roswellpark.org   
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: General CART Inquiry Email       CART@mskcc.org   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Cancer Awareness Line    216-444-2200      
Sponsors and Collaborators
Synthekine
More Information
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Responsible Party: Synthekine
ClinicalTrials.gov Identifier: NCT05665062    
Other Study ID Numbers: STK-009-101
First Posted: December 27, 2022    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Synthekine:
CART
CD19-CART
Chimeric antigen receptor
IL-2
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Hematologic Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Neoplasms by Site
 Hematologic Diseases
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists