- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05665062
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Clinical Operations
- Phone Number: 650.271.9888
- Email: clinicaltrialinfo@synthekine.com
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope
-
Contact:
- Michael Mei, MD
- Phone Number: 626-218-1133
-
-
New York
-
Buffalo, New York, United States, 14263
- Recruiting
- Roswell Park
-
Contact:
- Megan Hughes
- Phone Number: 7298 716-845-1300
- Email: megan.hughes@roswellpark.org
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- General CART Inquiry Email
- Email: CART@mskcc.org
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- Cancer Awareness Line
- Phone Number: 216-444-2200
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
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 |
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
STK-009 is a human orthogonal IL-2 cytokine selective for SYNCAR-001 CAR-T cells expressing hoRb
lymphodepletion
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 |
SYNCAR-001 is an autologous CD19-targeted CAR-T with co-expression of hoRb
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Neoplasms by Site
- Hematologic Diseases
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Hematologic Neoplasms
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
Other Study ID Numbers
- STK-009-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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