Mantle Cell Lymphoma Clinical Trial
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
This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | November 2026 |
Est. primary completion date | June 24, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park | Buffalo | New York |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | City of Hope | Duarte | California |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Synthekine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Up to 28 days post infusion (SYNCAR-001+STK-009) | |
Primary | Adverse events | 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 | Objective response rate (ORR) | The ORR to treatment with SYNCAR-001 + STK-009 | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | Duration of Response (DOR) | To evaluate the duration of anti-cancer response after SYNCAR-001 + STK-009 administration. | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | 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. | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | Area under the curve (AUC) | The quantification of the cumulative amount of drug over time. | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | Maximum Concentration (Cmax) | To identify the maximum (peak) drug concentration dosing. | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | Time of maximum concentration | The time to reach maximum (peak) drug concentration after dosing. | Up to 24 months post infusion (SYNCAR-001+STK-009) | |
Secondary | 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) | Up to 24 months post infusion (SYNCAR-001+STK-009) |
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