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

Primary Purpose

CLL/SLL, NHL, Mantle Cell Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SYNCAR-001
STK-009
Cyclophosphamide
Fludarabine
Sponsored by
Synthekine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CLL/SLL focused on measuring CART, CD19-CART, Chimeric antigen receptor, IL-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • Roswell Park
  • Columbia University Irving Medical CenterRecruiting
  • Memorial Sloan Kettering Cancer Center
  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYNCAR-001 + STK-009

Arm Description

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 extension: 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

Outcomes

Primary Outcome Measures

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
Adverse events
Assess the safety and tolerability of STK-009 in combination with SYNCAR-001 by review of AEs

Secondary Outcome Measures

Objective response rate (ORR)
The ORR to treatment with SYNCAR-001 + STK-009
Duration of Response (DOR)
To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration.
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.
Area under the curve (AUC)
The quantification of the cumulative amount of drug over time.
Maximum Concentration (Cmax)
To identify the maximum (peak) drug concentration dosing.
Time of maximum concentration
The time to reach maximum (peak) drug concentration after dosing.
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)

Full Information

First Posted
December 8, 2022
Last Updated
February 8, 2023
Sponsor
Synthekine
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1. Study Identification

Unique Protocol Identification Number
NCT05665062
Brief Title
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthekine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
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 dose escalation design followed by a dose extension phase at the recommended phase 2 dose (RP2D)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CLL/SLL, NHL, Mantle Cell Lymphoma, Follicular Lymphoma, Large B-cell Lymphoma, Indolent B-Cell Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
Keywords
CART, CD19-CART, Chimeric antigen receptor, IL-2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SYNCAR-001 + STK-009
Arm Type
Experimental
Arm Description
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 extension: 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
Intervention Type
Drug
Intervention Name(s)
SYNCAR-001
Intervention Description
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
Intervention Type
Drug
Intervention Name(s)
STK-009
Intervention Description
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
lymphodepletion
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
lymphodepletion
Primary Outcome Measure Information:
Title
Dose Limiting Toxicities (DLTs)
Description
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)
Title
Adverse events
Description
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)
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The ORR to treatment with SYNCAR-001 + STK-009
Time Frame
Up to 24 months post infusion (SYNCAR-001+STK-009)
Title
Duration of Response (DOR)
Description
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)
Title
Progression Free Survival (PFS)
Description
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)
Title
Area under the curve (AUC)
Description
The quantification of the cumulative amount of drug over time.
Time Frame
Up to 24 months post infusion (SYNCAR-001+STK-009)
Title
Maximum Concentration (Cmax)
Description
To identify the maximum (peak) drug concentration dosing.
Time Frame
Up to 24 months post infusion (SYNCAR-001+STK-009)
Title
Time of maximum concentration
Description
The time to reach maximum (peak) drug concentration after dosing.
Time Frame
Up to 24 months post infusion (SYNCAR-001+STK-009)
Title
Immunogenicity
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Operations
Phone
650.271.9888
Email
clinicaltrialinfo@synthekine.com
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Mei, MD
Phone
626-218-1133
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nurse Navigator
Phone
212-342-5162
Email
cancerclinicaltrials@cumc.columbia.edu
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer Awareness Line
Phone
216-444-2200

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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